NCT04229745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

November 26, 2019

Last Update Submit

January 13, 2020

Conditions

Pre-oxygenation in Term Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • EN90 using THRIVE with mouth open versus mouth closed

    8 months study period

  • comfort score of THRIVE

    8 months study period

  • changes in fetal wellbeing during pre-oxygenation time

    8 months study period

Interventions

THRIVE pre-oxygenationDEVICE

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

term pregnant women undergoing elective Caesarean section

You may qualify if:

  • scheduled to undergo elective caesarean delivery
  • singleton pregnancy
  • American Society of Anaesthesiologists (ASA) Physical Status Grade II
  • gestational age between 37 - 42 weeks

You may not qualify if:

  • multiple pregnancy
  • pre-eclampsia
  • known fetal abnormality
  • maternal cardio-respiratory comorbidity
  • Body Mass Index (BMI) \> 35 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLH

London, NW1 2BU, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

November 26, 2019

First Posted

January 18, 2020

Study Start

October 25, 2018

Primary Completion

June 23, 2019

Study Completion

June 23, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

GB(1)