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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04229745

Acronym

THRIVEN90

Enrollment

Registered

2020-01-18

Start date

2018-10-25

Completion date

2019-06-23

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-oxygenation in Term Pregnant Women

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.

Interventions

DEVICETHRIVE pre-oxygenation

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
comfort score of THRIVE	8 months study period	using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)
changes in fetal wellbeing during pre-oxygenation time	8 months study period	using fetal cardiotocography

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026