- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04229745
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery (THRIVEN90)
January 13, 2020 updated by: SABA AL-SULTTAN
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, NW1 2BU
- UCLH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
term pregnant women undergoing elective Caesarean section
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8 months study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EN90 using THRIVE with mouth open versus mouth closed
Time Frame: 8 months study period
|
to measure any difference in end tidal oxygen concentration after using THRIVE mouth closed versus THRIVE mouth open
|
8 months study period
|
comfort score of THRIVE
Time Frame: 8 months study period
|
using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)
|
8 months study period
|
changes in fetal wellbeing during pre-oxygenation time
Time Frame: 8 months study period
|
using fetal cardiotocography
|
8 months study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 25, 2018
Primary Completion (ACTUAL)
June 23, 2019
Study Completion (ACTUAL)
June 23, 2019
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
January 13, 2020
First Posted (ACTUAL)
January 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 18/0042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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