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Health Technology Assessment... Dec 2016Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use.
OBJECTIVES
To systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults.
DATA SOURCES
Electronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms.
REVIEW METHODS
This review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis.
RESULTS
We included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [ = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04; = 0.13; = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs ( = 2403, OR 0.62, 95% CI 0.44 to 0.86; = 0.01; = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays.
LIMITATIONS
It was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available.
CONCLUSIONS
The effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42015020710.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Fibrin Tissue Adhesive; Hematoma; Humans; Length of Stay; Observational Studies as Topic; Operative Time; Pain, Postoperative; Postoperative Complications; Quality of Life; Randomized Controlled Trials as Topic; Reoperation; Seroma; Surgical Procedures, Operative; Surgical Wound Infection
PubMed: 28051764
DOI: 10.3310/hta20940 -
Vibration and bubbles: a systematic review of the effects of helicopter retrieval on injured divers.Diving and Hyperbaric Medicine Dec 2018Vibration from a helicopter during aeromedical retrieval of divers may increase venous gas emboli (VGE) production, evolution or distribution, potentially worsening the...
INTRODUCTION
Vibration from a helicopter during aeromedical retrieval of divers may increase venous gas emboli (VGE) production, evolution or distribution, potentially worsening the patient's condition.
AIM
To review the literature surrounding the helicopter transport of injured divers and establish if vibration contributes to increased VGE.
METHOD
A systematic literature search of key databases was conducted to identify articles investigating vibration and bubbles during helicopter retrieval of divers. Level of evidence was graded using the Oxford Centre for Evidence-Based Medicine guidelines. A modified quality assessment tool for studies with diverse designs (QATSDD) was used to assess the overall quality of evidence.
RESULTS
Seven studies were included in the review. An in vitro research paper provided some evidence of bubble formation with gas supersaturation and vibration. Only one prospective intervention study was identified which examined the effect of vibration on VGE formation. Bubble duration was used to quantify VGE load with no difference found between the vibration and non-vibration time periods. This study was published in 1980 and technological advances since that time suggest cautious interpretation of the results. The remaining studies were retrospective chart reviews of helicopter retrieval of divers. Mode of transport, altitude exposure, oxygen and intravenous fluids use were examined.
CONCLUSION
There is some physical evidence that vibration leads to bubble formation although there is a paucity of research on the specific effects of helicopter vibration and VGE in divers. Technological advances have led to improved assessment of VGE in divers and will aid in further research.
Topics: Air Ambulances; Decompression Sickness; Diving; Embolism, Air; Humans; Prospective Studies; Retrospective Studies; Vibration
PubMed: 30517957
DOI: 10.28920/dhm48.4.241-251 -
Journal of Emergencies, Trauma, and... 2019Missile embolism (ME) is a rare condition and was seen in 0.3% of gunshot wounds during the Vietnam War. It was first reported by Thomas Davis in 1834. ME occurs when a...
Missile embolism (ME) is a rare condition and was seen in 0.3% of gunshot wounds during the Vietnam War. It was first reported by Thomas Davis in 1834. ME occurs when a small caliber, slow velocity projectile penetrates a wall in the vasculature; loses its kinetic energy; and gets carried away along the bloodstream to occlude another vessel at a distant site. Civilian victims of low-velocity bullets account for 60% of such cases. ME can be arterial, venous, or paradoxical. Systemic arterial embolization accounts for 80% of published reports and occurs after the projectile penetrates the left chambers of heart, aorta, or very rarely pulmonary veins (PVs). There are only nine published reports of ME through PV till date. We report here, embolism of an air-gun pellet entering through the right thorax, into right PV, embolizing into right femoral artery, causing acute limb ischemia, in a young male. Emergency arteriotomy and removal of the embolic pellet saved the limb with good recovery. He did not require a thoracotomy. The clinical picture, radiological findings, operative details, and the management are presented and discussed with relevant literature. The purpose of this report is to highlight the unique presentation of ME through PV, as its management is different from other cases of arterial ME. Early diagnosis of the condition is imperative to prevent permanent ischemic damage of end organ and its sequelae. We present an analysis of all published reports of systemic ME through PV and also give our recommendations for its management.
PubMed: 31543646
DOI: 10.4103/JETS.JETS_59_19 -
Neurologia I Neurochirurgia Polska 2021Pneumocephalus is a clinical entity characterised by the presence of gas in the intracranial space. It can result from many different causes. The most common cause is...
INTRODUCTION
Pneumocephalus is a clinical entity characterised by the presence of gas in the intracranial space. It can result from many different causes. The most common cause is head or facial trauma. Other causes include neoplasms, infections, and surgical or diagnostic procedures. Spontaneous non-traumatic pneumocephalus is a rare condition caused by bone defects, malformations, infections, tumours, intravenous air injection, and other causes. This review, supplemented with a case presentation, aims to summarise the current state of knowledge regarding non-traumatic pneumocephalus.
METHODOLOGY
This review involved an electronic search (PubMed, Scopus, Embase, and Web of Science) to identify studies regarding non-traumatic pneumocephalus. In addition, reference lists of identified articles were screened for other potentially relevant papers.
RESULTS
In total, 1,107 articles were retrieved by searching databases with the selected query. Based on the selection process, 134 articles were included. These articles were then classified into 'otogenic', 'bone defect', 'malformations', 'infectious', 'tumours', 'associated with intravenous air injection', and other categories.
CONCLUSION
Spontaneous non-traumatic pneumocephalus is a rare condition. Symptoms, clinical courses, and prognoses vary depending on the underlying cause of the disease. To the best of our knowledge, this review's example is the first case report of spontaneous pneumocephalus due to air embolism secondary to lung cancer.
Topics: Humans; Pneumocephalus
PubMed: 33543469
DOI: 10.5603/PJNNS.a2021.0014 -
The Cochrane Database of Systematic... Jul 2020Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common...
BACKGROUND
Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity. An earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions.
OBJECTIVES
To determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually). We included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness. External uterine compression versus normal care (1 trial, 64 women) Very low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23). Uterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women) The available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41). Intrauterine Tamponade Studies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze. Balloon tamponade versus normal care (2 trials, 356 women) One study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12). Bakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women) In this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence. Comparison of intrauterine tamponade methods (3 trials, 328 women) One study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06). A second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97). A third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty. Modified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women) Low-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75).
AUTHORS' CONCLUSIONS
There is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment. The finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.
Topics: Bias; Blood Transfusion; Female; Hemostasis, Surgical; Hemostatic Techniques; Humans; Hysterectomy; Postpartum Hemorrhage; Pressure; Randomized Controlled Trials as Topic; Suture Techniques; Uterine Artery Embolization; Uterine Balloon Tamponade
PubMed: 32609374
DOI: 10.1002/14651858.CD013663 -
European Review For Medical and... Nov 2018We performed a systematic review of the literature starting from a real case of venous air embolism (VAE) in a young infant undergoing central catheterization during...
We performed a systematic review of the literature starting from a real case of venous air embolism (VAE) in a young infant undergoing central catheterization during procedural sedation. Air embolism due to internal jugular vein catheterization during procedural sedation is very rare, but it is a potentially life-threatening complication of central catheterization that warrants attention. To our knowledge, this is the first case published in a similar scenario.
Topics: Catheterization, Central Venous; Deep Sedation; Embolism, Air; Humans; Infant; Male; Pulmonary Embolism
PubMed: 30536338
DOI: 10.26355/eurrev_201811_16418