Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Time Frame: 8 months study period
measure end tidal oxygen concentration through breathing system attached to anaesthetic machine
Secondary Outcomes
- comfort score of THRIVE(8 months study period)
- EN90 using THRIVE with mouth open versus mouth closed(8 months study period)
- changes in fetal wellbeing during pre-oxygenation time(8 months study period)
Investigators
SABA AL-SULTTAN
Research fellow
University College London Hospitals