Characterisation of human urethral rupture thresholds for urinary catheter inflation related injuries

Data on urethral catheter related injuries is sparse. In this study we aimed to characterise urethral diametric strain and urinary catheter inflation pressure thresholds that precede human urethral trauma during urethral catheterisation (UC). Human urethras were obtained from patients undergoing male to female gender reassignment surgery [(n = 9; age 40 ± 13.13 (range: 18–58)) years]. 12Fr urinary catheters were secured in the bulbar urethra and the catheter's anchoring balloon was inflated with a syringe pump apparatus. Urethral diametric strain and balloon pressure were characterised with video extensometry and a pressure transducer respectively. Immunohistochemistry, Masson's trichrome and Verhoeff-Van Gieson stains evaluated urethral trauma microscopically. Morphological characterisation of the urethral lumen was performed by examining non-traumatised histological sections of urethra and recording luminal area, perimeter and major/minor axis length. Tearing (n = 3) and rupture (n = 3) of the urethra were observed following catheter balloon inflation. The threshold for human urethral rupture occurred at an external urethral diametric strain ≥ 27% and balloon inflation pressure ≥ 120kPa. Significant relationships were identified between urethral wall thickness and the level of trauma induced during catheter balloon inflation (p = 0.001) and between the pressure required to inflate the catheter balloon and the length of the major axis of the urethral lumen (p = 0.004). Ruptured urethras demonstrated complete transection of collagen, elastin and muscle fibres. In conclusion, urethral rupture occurs at an external urethral diametric strain ≥ 27% or with balloon inflation pressures ≥ 120 kPa. Incorporation of these parameters may be useful for designing a safety mechanism for preventing catheter inflation related urethral injuries

Clinical evaluation of a safety-device to prevent urinary catheter inflation related injuries

OBJECTIVE: To evaluate the feasibility of a novel “safety-valve” device for preventing catheter related urethral trauma during urethral catheterization (UC). To assess the opinions of clinicians on the performance of the safety-valve device. MATERIALS AND METHODS A validated prototype “safety-valve” device for preventing catheter balloon inflation related urethral injuries was prospectively piloted in male patients requiring UC in a tertiary referral teaching hospital (n = 100). The device allows fluid in the catheter system to decant through an activated safety threshold pressure valve if the catheter anchoring balloon is misplaced. Users evaluated the “safety-valve” with an anonymous questionnaire. The primary outcome measurement was prevention of anchoring balloon inflation in the urethra. Secondary outcome measurement was successful inflation of urinary catheter anchoring balloon in the bladder. RESULTS: Patient age was 76 ± 12 years and American Society of Anaesthesiologists grade was 3 ± 1.4. The “safety-valve” was utilized by 34 clinicians and activated in 7% (n = 7/100) patients during attempted UC, indicating that the catheter anchoring balloon was incorrectly positioned in the patient’s urethra. In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 31 of 34 (91%) clinicians completed the questionnaire. Ten percent (n = 3/31) of respondents had previously inflated a urinary catheter anchoring balloon in the urethra and 100% (n = 31) felt that a safety mechanism for preventing balloon inflation in the urethra should be compulsory for all UCs. CONCLUSION: The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries

Consensus definition of fetal growth restriction in intrauterine fetal death a delphi procedure

Context.—Fetal growth restriction is a risk factor for intrauterine fetal death. Currently, definitions of fetal growth restriction in stillborns are heterogeneous. Objectives.—To develop a consensus definition for fetal growth restriction retrospectively diagnosed at fetal autopsy in intrauterine fetal death. Design.—A modified online Delphi survey in an international panel of experts in perinatal pathology, with feedback at group level and exclusion of nonresponders. The survey scoped all possible variables with an open question. Variables suggested by 2 or more experts were scored on a 5-point Likert scale. In subsequent rounds, inclusion of variables and thresholds were determined with a 70% level of agreement. In the final rounds, participants selected the consensus algorithm. Results.—Fifty-two experts participated in the first round; 88% (46 of 52) completed all rounds. The consensus definition included antenatal clinical diagnosis of fetal growth restriction OR a birth weight lower than third percentile OR at least 5 of 10 contributory variables (risk factors in the clinical antenatal history: birth weight lower than 10th percentile, body weight at time of autopsy lower than 10th percentile, brain weight lower than 10th percentile, foot length lower than 10th percentile, liver weight lower than 10th percentile, placental weight lower than 10th percentile, brain weight to liver weight ratio higher than 4, placental weight to birth weight ratio higher than 90th percentile, histologic or gross features of placental insufficiency/ malperfusion). There was no consensus on some aspects, including how to correct for interval between fetal death and delivery. Conclusions.—A consensus-based definition of fetal growth restriction in fetal death was determined with utility to improve management and outcomes of subsequent pregnancies