Preoxygenation Using THRIVE Versus Facemask in Parturients

Preoxygenation Clinical Trial

Official title:

Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772574
• Other study ID #: H18-02855
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 24, 2020

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 24, 2020
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Preoxygenation

Intervention

Device:
• Facemask preoxygenation
Standard facemask preoxygenation
• THRIVE preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoxygenation Duration	Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.	Maximum 8 minutes
Secondary	Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes		3 minutes of pre-oxygenation
Secondary	Proportion to Reach EtO2 of 90 Percent at 4 Minutes		4 minutes of preoxygenation
Secondary	Proportion to Reach EtO2 of 90 Percent at 5 Minutes		5 minutes of preoxygenation
Secondary	Proportion to Reach EtO2 of 90 Percent at 6 Minutes		6 minutes of preoxygenation
Secondary	Proportion to Reach EtO2 of 90 Percent at 7 Minutes		7 minutes of preoxygenation
Secondary	Proportion to Reach EtO2 of 90 Percent at 8 Minutes		8 minutes of preoxygenation
Secondary	Comfort Score	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)	1 minute after data collection
Secondary	Acceptability Score	Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).	1 minute after data collection