Preoxygenation Clinical Trial
Official title:
Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients
Verified date | May 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | BC Women's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
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 |
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