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

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
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

SABA AL-SULTTAN

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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