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BMJ Open Feb 2021To identify, appraise and synthesise studies evaluating the downsides of wearing face masks in any setting. We also discuss potential strategies to mitigate these... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To identify, appraise and synthesise studies evaluating the downsides of wearing face masks in any setting. We also discuss potential strategies to mitigate these downsides.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
PubMed, Embase, CENTRAL and EuropePMC were searched (inception-18 May 2020), and clinical registries were searched via CENTRAL. We also did a forward-backward citation search of the included studies.
INCLUSION CRITERIA
We included randomised controlled trials and observational studies comparing face mask use to any active intervention or to control.
DATA EXTRACTION AND ANALYSIS
Two author pairs independently screened articles for inclusion, extracted data and assessed the quality of included studies. The primary outcomes were compliance, discomforts, harms and adverse events of wearing face masks.
RESULTS
We screened 5471 articles, including 37 (40 references); 11 were meta-analysed. For mask wear adherence, 47% (95% CI 25% to 68%, p<0.0001), more people wore face masks in the face mask group compared with control; adherence was significantly higher (26%, 95% CI 8% to 46%, p<0.01) in the surgical/medical mask group than in N95/P2 group. The largest number of studies reported on the discomfort and irritation outcome (20 studies); fewest reported on the misuse of masks, and none reported on mask contamination or risk compensation behaviour. Risk of bias was generally high for blinding of participants and personnel and low for attrition and reporting biases.
CONCLUSIONS
There are insufficient data to quantify all of the adverse effects that might reduce the acceptability, adherence and effectiveness of face masks. New research on face masks should assess and report the harms and downsides. Urgent research is also needed on methods and designs to mitigate the downsides of face mask wearing, particularly the assessment of possible alternatives.
SYSTEMATIC REVIEW REGISTRATION
Open Science Framework website https://osf.io/sa6kf/ (timestamp 20-05-2020).
Topics: Humans; Masks; Randomized Controlled Trials as Topic
PubMed: 33619199
DOI: 10.1136/bmjopen-2020-044364 -
PeerJ 2023Surgical masks remain a focal part of the CDC guidelines to decrease COVID-19 transmission. Evidence refuting significant effects of masking on ventilation is mostly... (Clinical Trial)
Clinical Trial
BACKGROUND
Surgical masks remain a focal part of the CDC guidelines to decrease COVID-19 transmission. Evidence refuting significant effects of masking on ventilation is mostly limited to small studies, with a paucity of studies on children, and none comparing children to adults.
METHODS
A total of 119 subjects were enrolled (71 adults, 49 children) in a prospective interventional study with each subject serving as their own mask-free control. End tidal CO2 (ETCO2), inspired CO2 (ICO2), and respiratory rate were measured by nasal cannula attached to an anesthesia machine D-fend module. Pulse oximetry and heart rate were also followed. After the mask-free period, an ASTM Level 3 disposable surgical mask was donned and 15 min of mask-worn data were collected.
RESULTS
A steady state was confirmed for ETCO2 and ICO2 over the masked period, and mean ICO2 levels rose significantly ( < 0.001) after masking in all age groups. The increase in ICO2 for the 2- to 7-year-old group of 4.11 mmHg (3.23-4.99), was significantly higher ( < 0.001) than the final ΔICO2 levels for both the 7- to 14-year-old group, 2.45 mmHg (1.79-3.12), and adults, 1.47 mmHg (1.18-1.76). For the pediatric group there was a negative, significant correlation between age and ΔICO2, r = -0.49, < 0.001. Masking resulted in a statistically significant ( < 0.01) rise in ETCO2 levels of 1.30 mmHg in adults and 1.36 mmHg in children. The final respective ETCO2 levels, 34.35 (33.55-35.15) and 35.07 (34.13-36.01), remained within normal limits. Pulse oximetry, heart rate, and respiratory rate were not significantly affected.
DISCUSSION
The physiology of mechanical dead space is discussed, including the inverse relationship of subject age ICO2. The methodology and results are compared to previously published studies which detracted from the physiologic safety of surgical masking.
CONCLUSIONS
The wearing of a surgical mask results in a statistically significant rise in ICO2 and a smaller rise in ETCO2. Because ETCO2 and other variables remain well within normal limits, these changes are clinically insignificant.
Topics: Humans; Child; Adult; Child, Preschool; Adolescent; Carbon Dioxide; Masks; Prospective Studies; COVID-19; Respiration
PubMed: 37342359
DOI: 10.7717/peerj.15474 -
Revista Brasileira de Enfermagem 2023to integrate evidence from studies on auditory perceptual and speech production effects in communication situations with face mask use. (Review)
Review
OBJECTIVES
to integrate evidence from studies on auditory perceptual and speech production effects in communication situations with face mask use.
METHODS
an integrative literature review, in MEDLINE, Cochrane Library and Embase databases. The guiding question was: what effects on communication (perceptual-auditory and speech production) occur with face mask use?
RESULTS
searches in electronic databases resulted in 1,478 studies and filtering resulted in 29 final studies.
CONCLUSIONS
mask use has effects on communication, both in perception and speech production, factors that are also related to quality of life, stress and socio-emotional factors. These data can impact on indicators and alerts in favor of adopting strategies to manage mask use, involving speech production and perception when wearing a mask in health services.
Topics: Humans; Masks; Quality of Life; Communication; Databases, Factual; Emotions
PubMed: 37820148
DOI: 10.1590/0034-7167-2022-0674 -
European Journal of Medical Research Aug 2020The German government has made it mandatory to wear respiratory masks covering mouth and nose (MNC) as an effective strategy to fight SARS-CoV-2 infections. In many... (Review)
Review
BACKGROUND
The German government has made it mandatory to wear respiratory masks covering mouth and nose (MNC) as an effective strategy to fight SARS-CoV-2 infections. In many countries, this directive has been extended on shopping malls or public transportation. The aim of this paper is to critically analyze the statutory regulation to wear protective masks during the COVID-19 crisis from a medical standpoint.
METHODS
We performed an extensive query of the most recent publications addressing the prevention of viral infections including the use of face masks in the community as a method to prevent the spread of the infection. We addressed the issues of practicability, professional use, and acceptability based on the community and the environment where the user resided.
RESULTS
Upon our critical review of the available literature, we found only weak evidence for wearing a face mask as an efficient hygienic tool to prevent the spread of a viral infection. However, the use of MNC seems to be linked to relevant protection during close contact scenarios by limiting pathogen-containing aerosol and liquid droplet dissemination. Importantly, we found evidence for significant respiratory compromise in patients with severe obstructive pulmonary disease, secondary to the development of hypercapnia. This could also happen in patients with lung infections, with or without SARS-CoV-2.
CONCLUSION
Epidemiologists currently emphasize that wearing MNC will effectively interrupt airborne infections in the community. The government and the politicians have followed these recommendations and used them to both advise and, in some cases, mandate the general population to wear MNC in public locations. Overall, the results seem to suggest that there are some clinically relevant scenarios where the use of MNC necessitates more defined recommendations. Our critical evaluation of the literature both highlights the protective effects of certain types of face masks in defined risk groups, and emphasizes their potential risks.
Topics: COVID-19; Coronavirus Infections; Equipment and Supplies Utilization; Humans; Masks; Pandemics; Pneumonia, Viral; Practice Guidelines as Topic; Pre-Exposure Prophylaxis; Respiratory Protective Devices
PubMed: 32787926
DOI: 10.1186/s40001-020-00430-5 -
The Cochrane Database of Systematic... Jul 2017The development of supraglottic airway devices has revolutionized airway management during general anaesthesia. Two devices are widely used in clinical practice to... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
The development of supraglottic airway devices has revolutionized airway management during general anaesthesia. Two devices are widely used in clinical practice to facilitate positive pressure ventilation: the ProSeal laryngeal mask airway (pLMA) and the Classic laryngeal mask airway (cLMA). It is not clear whether these devices have important clinical differences in terms of efficacy or complications.
OBJECTIVES
To compare the effectiveness of the ProSeal laryngeal mask airway (pLMA) and the Classic LMA (cLMA) for positive pressure ventilation in adults undergoing elective surgery.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 3) in the Cochrane Library; MEDLINE (Ovid SP, 1997 to April 2017); Embase (Ovid SP, 1997 to April 2017); the Institute for Scientific Information (ISI) Web of Science (1946 to April 2017); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO host, 1982 to April 2017).We searched trial registries for ongoing studies to April 2017.We did not impose language restrictions. We restricted our search to the time from 1997 to April 2017 because pLMA was introduced into clinical practice in the year 2000.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared the effectiveness of pLMA and cLMA for positive pressure ventilation in adults undergoing elective surgery. We planned to include only data related to the first phase of cross-over RCTs.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by the Cochrane Collaboration.
MAIN RESULTS
We included eight RCTs that involved a total of 829 participants (416 and 413 participants in the pLMA and cLMA groups, respectively). We identified six cross-over studies that are awaiting classification; one is completed but has not been published, and data related to the first treatment period for the other five studies were not yet available. Seven included studies provided data related to the primary outcome, and eight studies provided data related to more than one secondary outcome.Our analysis was hampered by the fact that a large proportion of the included studies reported no events in either study arm. No studies reported significant differences between devices in relation to the primary review outcome: failure to adequately mechanically ventilate. We evaluated this outcome by assessing two variables: inadequate oxygenation (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.17 to 3.31; four studies, N = 617) and inadequate ventilation (not estimable; one study, N = 80).More time was required to establish an effective airway using pLMA (mean difference (MD) 10.12 seconds, 95% CI 5.04 to 15.21; P < 0.0001; I² = 73%; two studies, N = 434). Peak airway pressure during positive pressure ventilation was lower in cLMA participants (MD 0.84, 95% CI 0.02 to 1.67; P = 0.04; I² = 0%; four studies, N = 259). Mean oropharyngeal leak (OPL) pressure was higher in pLMA participants (MD 6.93, 95% CI 4.23 to 9.62; P < 0.00001; I² = 87%; six studies, N = 709).The quality of evidence for all outcomes, as assessed by GRADE score, is low mainly owing to issues related to blinding and imprecision.Data show no important differences between devices with regard to failure to insert the device, use of an alternate device, mucosal injury, sore throat, bronchospasm, gastric insufflation, regurgitation, coughing, and excessive leak. Data were insufficient to allow estimation of differences for obstruction related to the device. None of the studies reported postoperative nausea and vomiting as an outcome.
AUTHORS' CONCLUSIONS
We are uncertain about the effects of either of the airway devices in terms of failure of oxygenation or ventilation because there were very few events. Results were uncertain in terms of differences for several complications. Low-quality evidence suggests that the ProSeal laryngeal mask airway makes a better seal and therefore may be more suitable than the Classic laryngeal mask airway for positive pressure ventilation. The Classic laryngeal mask airway may be quicker to insert, but this is unlikely to be clinically meaningful.
Topics: Adult; Elective Surgical Procedures; Humans; Laryngeal Masks; Oxygen Consumption; Positive-Pressure Respiration; Randomized Controlled Trials as Topic; Treatment Failure
PubMed: 28727896
DOI: 10.1002/14651858.CD009026.pub2 -
The Cochrane Database of Systematic... Nov 2022Nasal masks and nasal prongs are used as interfaces for providing continuous positive airway pressure (CPAP) for preterm infants with or at risk of respiratory distress,... (Review)
Review
BACKGROUND
Nasal masks and nasal prongs are used as interfaces for providing continuous positive airway pressure (CPAP) for preterm infants with or at risk of respiratory distress, either as primary support after birth or as ongoing support after endotracheal extubation from mechanical ventilation. It is unclear which type of interface is associated with lower rates of CPAP treatment failure, nasal trauma, or mortality and other morbidity.
OBJECTIVES
To assess the benefits and harms of nasal masks versus nasal prongs for reducing CPAP treatment failure, nasal trauma, or mortality and other morbidity in newborn preterm infants with or at risk of respiratory distress.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was October 2021.
SELECTION CRITERIA
We included randomised controlled trials comparing masks versus prongs as interfaces for delivery of nasal CPAP in newborn preterm infants (less than 37 weeks' gestation) with or at risk of respiratory distress.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. treatment failure, 2. all-cause mortality, and 3. neurodevelopmental impairment. Our secondary outcomes were 4. pneumothorax, 5. moderate-severe nasal trauma, 6. bronchopulmonary dysplasia, 7. duration of CPAP use, 8. duration of oxygen supplementation, 9. duration of hospitalisation, 10. patent ductus arteriosus receiving medical or surgical treatment, 11. necrotising enterocolitis, 12. severe intraventricular haemorrhage, and 13. severe retinopathy of prematurity. We used the GRADE approach to assess the certainty of the evidence.
MAIN RESULTS
We included 12 trials with 1604 infants. All trials were small (median number of participants 118). The trials occurred after 2001 in care facilities internationally, predominantly in India (eight trials). Most participants were preterm infants of 26 to 34 weeks' gestation who received nasal CPAP as the primary form of respiratory support after birth. The studied interfaces included commonly used commercially available masks and prongs. Lack of measures to blind caregivers or investigators was a potential source of performance and detection bias in all the trials. Meta-analyses suggested that use of masks compared with prongs may reduce CPAP treatment failure (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.58 to 0.90; 8 trials, 919 infants; low certainty). The type of interface may not affect mortality prior to hospital discharge (RR 0.83, 95% CI 0.56 to 1.22; 7 trials, 814 infants; low certainty). There are no data on neurodevelopmental impairment. Meta-analyses suggest that the choice of interface may result in little or no difference in the risk of pneumothorax (RR 0.93, 95% CI 0.45 to 1.93; 5 trials, 625 infants; low certainty). Use of masks rather than prongs may reduce the risk of moderate-severe nasal injury (RR 0.55, 95% CI 0.44 to 0.71; 10 trials, 1058 infants; low certainty). The evidence is very uncertain about the effect on bronchopulmonary dysplasia (RR 0.69, 95% CI 0.46 to 1.03; 7 trials, 843 infants; very low certainty).
AUTHORS' CONCLUSIONS
The available trial data provide low-certainty evidence that use of masks compared with prongs as the nasal CPAP interface may reduce treatment failure and nasal injury, and may have little or no effect on mortality or the risk of pneumothorax in newborn preterm infants with or at risk of respiratory distress. The effect on bronchopulmonary dysplasia is very uncertain. Large, high-quality trials would be needed to provide evidence of sufficient validity and applicability to inform policy and practice.
Topics: Humans; Infant, Newborn; Continuous Positive Airway Pressure; Infant, Premature; Bronchopulmonary Dysplasia; Masks; Pneumothorax; Respiratory Distress Syndrome
PubMed: 36374241
DOI: 10.1002/14651858.CD015129 -
Journal of the American Medical... Jul 2021
Topics: COVID-19; Humans; Masks; Medical Informatics
PubMed: 34261133
DOI: 10.1093/jamia/ocab130 -
Annals of Internal Medicine Jun 2023Optimal use of masks for preventing COVID-19 is unclear. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Optimal use of masks for preventing COVID-19 is unclear.
PURPOSE
To update an evidence synthesis on N95, surgical, and cloth mask effectiveness in community and health care settings for preventing SARS-CoV-2 infection.
DATA SOURCES
MEDLINE, EMBASE, medRxiv (3 June 2022 to 2 January 2023), and reference lists.
STUDY SELECTION
Randomized trials of interventions to increase mask use and risk for SARS-CoV-2 infection and observational studies of mask use that controlled for potential confounders.
DATA EXTRACTION
Two investigators sequentially abstracted study data and rated quality.
DATA SYNTHESIS
Three randomized trials and 21 observational studies were included. In community settings, mask use may be associated with a small reduced risk for SARS-CoV-2 infection versus no mask use, on the basis of 2 randomized trials and 7 observational studies. In routine patient care settings, surgical masks and N95 respirators may be associated with similar risk for SARS-CoV-2 infection, on the basis of 1 new randomized trial with some imprecision and 4 observational studies. Evidence from observational studies was insufficient to evaluate other mask comparisons due to methodological limitations and inconsistency.
LIMITATION
Few randomized trials, studies had methodological limitations and some imprecision, suboptimal adherence and pragmatic aspects of randomized trials potentially attenuated benefits, very limited evidence on harms, uncertain applicability to Omicron variant predominant era, meta-analysis not done due to heterogeneity, unable to formally assess for publication bias, and restricted to English-language articles.
CONCLUSION
Updated evidence suggests that masks may be associated with a small reduction in risk for SARS-CoV-2 infection in community settings. Surgical masks and N95 respirators may be associated with similar infection risk in routine patient care settings, but a beneficial effect of N95 respirators cannot be ruled out.
PRIMARY FUNDING SOURCE
None.
Topics: Humans; SARS-CoV-2; COVID-19; Masks; Delivery of Health Care
PubMed: 37186920
DOI: 10.7326/M23-0570 -
Frontiers in Public Health 2022Since the emergence of COVID-19, mandatory facemask wearing has been implemented around the world to prevent viral transmission, however, the impact of wearing facemasks... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Since the emergence of COVID-19, mandatory facemask wearing has been implemented around the world to prevent viral transmission, however, the impact of wearing facemasks on patients with COPD was unclear.
METHODS
The current study undertakes a systematic review and meta-analysis of a comprehensive literature retrieval from six databases, based on the pre-determined eligibility criteria, irrespective of language. The risk of bias was assessed using an established instrument. We primarily focused on analyzing ETCO, SpO, and heart and respiratory rates, and also considered the impacts on physiological and exercise performance. A descriptive summary of the data and possible meta-analysis was performed. Forest plots were generated to pool estimates based on each of the study outcomes.
RESULTS
Of the 3,751 publications considered, six publications were selected for a systematic review and two publications were included for meta-analysis, however, the quality of these six studies was relatively low overall. In the case of inactivity, the facemask wearing COPD cohort had higher respiratory rates than that of the non-facemask wearing cohort (MD = 1.00 and 95% CI 0.47-1.53, < 0.05). There was no significant difference in ETCO (MD = 0.10 and 95% CI -1.57-1.78, > 0.05) and heart rate (MD = 0.40 and 95% CI -3.59-4.39, > 0.05) nor SpO (MD = -0.40 and 95% CI -0.84-0.04, > 0.05) between the COPD patients with and without facemasks. Furthermore, it was observed that the only significant differences between the COPD patients with and without facemasks undertaking different activities were FEV1 (%) (MD = 3.84 and 95% CI 0.14-7.54, < 0.05), FEV1/FVC (%) (MD = 3.25 and 95% CI 0.71-5.79, < 0.05), and blood lactate (MD = -0.90 and 95% CI -1.73 to -0.07, < 0.05).
CONCLUSION
Wearing facemasks decreased the exercise performance of patients with COPD, however, it had minimal impact on physiological indexes. Further investigations will be performed on the high-quality data from randomized control studies.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=326265, identifier: CRD42022326265.
Topics: Humans; COVID-19; Masks; Personal Protective Equipment; Sedentary Behavior; Pulmonary Disease, Chronic Obstructive
PubMed: 36466486
DOI: 10.3389/fpubh.2022.1027521 -
Frontiers in Public Health 2022Face coverings and distancing as preventative measures against the spread of the Coronavirus disease 2019 may impact communication in several ways that may...
INTRODUCTION
Face coverings and distancing as preventative measures against the spread of the Coronavirus disease 2019 may impact communication in several ways that may disproportionately affect people with hearing loss. A scoping review was conducted to examine existing literature on the impact of preventative measures on communication and to characterize the clinical implications.
METHOD
A systematic search of three electronic databases (Scopus, PubMed, CINAHL) was conducted yielding 2,158 articles. After removing duplicates and screening to determine inclusion eligibility, key data were extracted from the 50 included articles. Findings are reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Extension for Scoping Reviews, including the PRISMA-ScR checklist.
RESULTS
Studies fell into three categories: Studies addressing the impacts of personal protective equipment (PPE) and/or distancing on communication in healthcare contexts ( = 20); studies examining the impact of preventative measures on communication in everyday life ( = 13), and studies measuring the impact of face coverings on speech using acoustic and/or behavioral measures ( = 29). The review revealed that masks disrupt verbal and non-verbal communication, as well as emotional and social wellbeing and they impact people with hearing loss more than those without. These findings are presumably because opaque masks attenuate sound at frequencies above 1 kHz, and conceal the mouth and lips making lipreading impossible, and limit visibility of facial expressions. While surgical masks cause relatively little sound attenuation, transparent masks and face shields are highly attenuating. However, they are preferred by people with hearing loss because they give access to visual cues.
CONCLUSION
Face coverings and social distancing has detrimental effects that extend well beyond verbal and non-verbal communication, by affecting wellbeing and quality of life. As these measures will likely be part of everyday life for the foreseeable future, we propose that it is necessary to support effective communication, especially in healthcare settings and for people with hearing loss.
Topics: COVID-19; Communication; Humans; Masks; Quality of Life; SARS-CoV-2
PubMed: 35419343
DOI: 10.3389/fpubh.2022.815259