Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
Completed
- Conditions
- Pre-oxygenation in Term Pregnant Women
- Registration Number
- NCT04229745
- Lead Sponsor
- SABA AL-SULTTAN
- Brief Summary
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- scheduled to undergo elective caesarean delivery
- singleton pregnancy
- American Society of Anaesthesiologists (ASA) Physical Status Grade II
- gestational age between 37 - 42 weeks
Exclusion Criteria
- multiple pregnancy
- pre-eclampsia
- known fetal abnormality
- maternal cardio-respiratory comorbidity
- Body Mass Index (BMI) > 35 kg/m2.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9 8 months study period measure end tidal oxygen concentration through breathing system attached to anaesthetic machine
- Secondary Outcome Measures
Name Time Method changes in fetal wellbeing during pre-oxygenation time 8 months study period using fetal cardiotocography
comfort score of THRIVE 8 months study period using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)
EN90 using THRIVE with mouth open versus mouth closed 8 months study period to measure any difference in end tidal oxygen concentration after using THRIVE mouth closed versus THRIVE mouth open
Trial Locations
- Locations (1)
UCLH
🇬🇧London, United Kingdom