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Completed

NCT Number: NCT04229745

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

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.

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Key information

Conditions

Pre-oxygenation in Term Pregnant Women

Sex eligibility

Female

Study type

Observational

Primary location

UCLH

London, NW1 2BU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THRIVE pre-oxygenation

Device

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

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

    Time frame: 8 months study period

    measure end tidal oxygen concentration through breathing system attached to anaesthetic machine

Secondary outcomes

  1. 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

  2. comfort score of THRIVE

    Time frame: 8 months study period

    using 4-point Likert scale (1 being very uncomfortable- 4 comfortable)

  3. changes in fetal wellbeing during pre-oxygenation time

    Time frame: 8 months study period

    using fetal cardiotocography

Sponsors and collaborators

Lead sponsor

SABA AL-SULTTAN

Other

Registry information

Acronym: THRIVEN90

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.