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OPTiMASK: Comparison of Pre-oxygenation With Standard Face Mask Combined With High Flow Nasal Oxygen With Pre-oxygenation With Standard Face Mask Alone

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ClinicalTrials.gov Identifier: NCT05495841
Recruitment Status : Recruiting
First Posted : August 10, 2022
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
This is an observational, prospective study of patients undergoing a surgical procedure. Three parallel studies are taking place with collaborators in other countries. This study aims to bring novel insights regarding the benefits of pre-oxygenation combining standard oxygen facemask with high-flow nasal oxygen (HFNO), as opposed to standard oxygen facemask alone by assessing end-tidal oxygen (ETO2) levels after intubation.

Condition or disease Intervention/treatment
Surgery Device: Pre-oxygenation

Detailed Description:

This is an observational, prospective study of patients undergoing a surgical procedure. A total of 80 patients will be enrolled at BIDMC. Patients meeting inclusion criteria with no exclusions will be approached for consent. 40 patients receiving the pre-oxygenation face mask alone method during clinical routine and 40 patients using the pre-oxygenation combined facemask + HFNO technique as part of routine clinical care will be studied. No randomization will be employed. Choice of pre-oxygenation approach is at the discretion of the clinician. Patients will be enrolled as a convenience sample, such that the first 40 patients will be those with face mask alone, and the second 40 will be patients with face mask + HFNO. Research assistants will discuss the pre-oxygenation plan with the anesthesiologist as part of the screening process. Data will be collected including EtO2 levels during two minutes following intubation.

Methodology

  1. Face mask alone: As per clinical standard, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes. In case of suspected full stomach, it is recommended to perform a rapid sequence induction and the patient does not receive bag-mask ventilation during the apnea period (45-60s). In the other case, a standard pre-oxygenation will be performed (see figure 1: experimental design of the study).
  2. Face mask + Nasal cannula: As to clinical standards, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes and HFNO at 100% with a flow at 40 L/minutes during the pre-oxygenation (the flow can be decreased to less than 40 L/minutes if no tolerance by the patient). Then, after a general anesthesia induction and/or a rapid sequence induction is performed, the patient receives HFNO at 100% FiO2 and the flow of HFNO is increased to up to 80 L/minutes (which corresponds to a close delivered FiO2 at 80%) during the apnea period (1 to 2 min) until correct position of the endotracheal tube is confirmed with capnography.

Assessments The study does not require any research procedures other than passive data collection. For this study, EtO2 levels will be recorded at more frequent intervals than what is entered in the anesthesia record. Therefore, study staff will collect these data from the anesthesia machine in the operating room, where values are displayed on a breath-by-breath basis

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPTiMASK: Comparison of Pre-oxygenation With Standard Face Mask Combined With High Flow Nasal Oxygen With Pre-oxygenation With Standard Face Mask Alone
Actual Study Start Date : August 18, 2022
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Face Mask Alone
40 patients receiving the pre-oxygenation face mask alone method during clinical routine will be studied. As per clinical standard, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes. In case of suspected full stomach, it is recommended to perform a rapid sequence induction and the patient does not receive bag-mask ventilation during the apnea period (45-60s). In the other case, a standard pre-oxygenation will be performed (see figure 1: experimental design of the study).
 Device: Pre-oxygenation
Process of administrating oxygen prior to intubation
Face Mask and Nasal Cannula
40 patients using the pre-oxygenation combined facemask + HFNO technique as part of routine clinical care will be studied. As to clinical standards, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes and HFNO at 100% with a flow at 40 L/minutes during the pre-oxygenation (the flow can be decreased to less than 40 L/minutes if no tolerance by the patient). Then, after a general anesthesia induction and/or a rapid sequence induction is performed, the patient receives HFNO at 100% FiO2 and the flow of HFNO is increased to up to 80 L/minutes (which corresponds to a close delivered FiO2 at 80%) during the apnea period (1 to 2 min) until correct position of the endotracheal tube is confirmed with capnography.
 Device: Pre-oxygenation
Process of administrating oxygen prior to intubation


Outcome Measures
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Primary Outcome Measures :
  1. Lowest EtO2 value [ Time Frame: start of intubation to 2 minutes after ]
    Lowest EtO2 value within the two minutes following tracheal intubation


Secondary Outcome Measures :
  1. SpO2 at the start and at the end of the procedure [ Time Frame: start of intubation to 4 minutes after ]
    SpO2 at the start and at the end of the procedure and EtO2 each minute during the four minutes of pre-oxygenation

  2. Tolerance of the device [ Time Frame: entirety of procedure ]
    Tolerance of the device (discomfort considered if the patient asks for reduction of the gas flow of HFNC: Yes or No

  3. Lowest SpO2 [ Time Frame: start of intubation to 2 minutes after ]
    Lowest SpO2 during intubation and within 2 min after intubation

  4. Highest level of EtCO2 [ Time Frame: start of intubation to 2 minutes after ]
    Highest level of EtCO2 within 2 min following intubation

  5. Rate of oxygen desaturation [ Time Frame: entirety of procedure ]
    Rate of oxygen desaturation below 95% during the procedure

  6. Number of laryngoscopy attempts [ Time Frame: before surgical procedure ]
    Number of laryngoscopy attempts before successful tracheal intubation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study accepts patients undergoing a surgical procedure. Patients would be considered for eligibility regardless of race, ethnicity or gender.
Criteria

Inclusion Criteria:

  • 18 years and older
  • All consecutive patients for scheduled or non-scheduled surgery with or without indication of rapid sequence induction (full-stomach)
  • Undergoing general anesthesia with orotracheal intubation

Exclusion Criteria:

  • Age < 18 years
  • Hemodynamic instability
  • Intubation without laryngoscopy (i.e., fiberoptic intubation for anticipated "cannot ventilate situation" or mouth opening < 2 cm), facial surgery
  • Adults subject to legal protection
  • Pregnancy (due to higher risk of oxygen desaturation and aspiration)
Contacts and Locations
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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): NCT05495841


Contacts
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Contact: Ryan Mathura, MPH 617-632-8067 rmathura@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel S Talmor, MD    617-632-8696    dtalmor@bidmc.harvard.edu   
Contact: Ryan Mathura, MPH    617-632-8067    rmathura@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Daniel S Talmor, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Daniel Talmor, Anesthesia Department Chair, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05495841    
Other Study ID Numbers: 2022P000396
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will conduct anonymous data collection in order to ensure the anonymity of each person participating in the study. No information allowing the identification of persons will be communicated to third parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No