Skip to main content
Clinical Trials/NCT04229745
NCT04229745
Completed
Not Applicable

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

SABA AL-SULTTAN1 site in 1 country20 target enrollmentOctober 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-oxygenation in Term Pregnant Women
Sponsor
SABA AL-SULTTAN
Enrollment
20
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2018
End Date
June 23, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
SABA AL-SULTTAN
Responsible Party
Sponsor Investigator
Principal Investigator

SABA AL-SULTTAN

Research fellow

University College London Hospitals

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • comfort score of THRIVE(8 months study period)
  • EN90 using THRIVE with mouth open versus mouth closed(8 months study period)
  • changes in fetal wellbeing during pre-oxygenation time(8 months study period)

Study Sites (1)

Loading locations...

Similar Trials