Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery

Pre-oxygenation in Term Pregnant Women Clinical Trial

— THRIVEN90  

Official title:

Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229745
• Other study ID #: 18/0042
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: June 23, 2019

Study information

• Verified date: January 2020
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 23, 2019
• Est. primary completion date: June 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-oxygenation in Term Pregnant Women

Intervention

Device:
• THRIVE pre-oxygenation
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery

Locations

Country	Name	City	State
United Kingdom	UCLH	London

Sponsors (1)

Lead Sponsor	Collaborator
SABA AL-SULTTAN

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	measure end tidal oxygen concentration through breathing system attached to anaesthetic machine	8 months study period
Secondary	EN90 using THRIVE with mouth open versus mouth closed	to measure any difference in end tidal oxygen concentration after using THRIVE mouth closed versus THRIVE mouth open	8 months study period
Secondary	comfort score of THRIVE	using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)	8 months study period
Secondary	changes in fetal wellbeing during pre-oxygenation time	using fetal cardiotocography	8 months study period