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Completed

NCT Number: NCT03772574

Preoxygenation Using THRIVE Versus Facemask in Parturients

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

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Key information

Conditions

Preoxygenation

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 >90%.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant patients ≥36 weeks gestation.
  • Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
  • American Society of Anesthesiologists (ASA) class 2.

Exclusion criteria

  • Any medical conditions that are likely to affect gas exchange.
  • Obstructed nasal passage.
  • Unable to tolerate a tight fitting facemask.
  • Body Mass Index ≥40 kg/m2.
  • Patients who are in active labor (i.e. cervical dilation ≥4cm).
  • Patients who are unable to give informed consent.

Treatment and study plan

Facemask preoxygenation

Device

Standard facemask preoxygenation

THRIVE preoxygenation

Device

Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Other names: THRIVE

Primary outcomes

  1. Preoxygenation Duration

    Time frame: Maximum 8 minutes

    Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.

Secondary outcomes

  1. Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes

    Time frame: 3 minutes of pre-oxygenation

  2. Proportion to Reach EtO2 of 90 Percent at 4 Minutes

    Time frame: 4 minutes of preoxygenation

  3. Proportion to Reach EtO2 of 90 Percent at 5 Minutes

    Time frame: 5 minutes of preoxygenation

  4. Proportion to Reach EtO2 of 90 Percent at 6 Minutes

    Time frame: 6 minutes of preoxygenation

  5. Proportion to Reach EtO2 of 90 Percent at 7 Minutes

    Time frame: 7 minutes of preoxygenation

  6. Proportion to Reach EtO2 of 90 Percent at 8 Minutes

    Time frame: 8 minutes of preoxygenation

  7. Comfort Score

    Time frame: 1 minute after data collection

    Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)

  8. Acceptability Score

    Time frame: 1 minute after data collection

    Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
May 24, 2022

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.

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