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Preoxygenation Using THRIVE Versus Facemask in Parturients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772574
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Anton Chau, University of British Columbia

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

Condition or disease Intervention/treatment Phase
Preoxygenation Device: Facemask preoxygenation Device: THRIVE preoxygenation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: THRIVE
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
Device: THRIVE preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Other Name: THRIVE

Active Comparator: Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Device: Facemask preoxygenation
Standard facemask preoxygenation




Primary Outcome Measures :
  1. Preoxygenation duration [ Time Frame: Maximum 8 minutes ]
    Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772574


Contacts
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Contact: James D Taylor, BSc 604-875-2424 ext 6076 james.taylor1@phsa.ca
Contact: Kelly Au, BSc MD 604-875-2424 ext 6076 kelly.au@cw.bc.ca

Locations
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Canada, British Columbia
BC Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: James D Taylor, BSc    604-875-2424 ext 6076    james.taylor1@phsa.ca   
Contact: Kelly Au, BSc MD    604-875-2424 ext 6076    kelly.au@cw.bc.ca   
Principal Investigator: Anton Chau, MD MMSc         
Sub-Investigator: Kelly Au, MD         
Sub-Investigator: William Shippam, MB BCh         
Sub-Investigator: James Taylor, BSc         
Sub-Investigator: Arianne Albert, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Anton Chau, MD MMSc University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anton Chau, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03772574    
Other Study ID Numbers: H18-02855
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action