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

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

Tracking Information

• First Submitted Date: August 4, 2022
• First Posted Date: August 10, 2022
• Last Update Posted Date: December 12, 2022
• Actual Study Start Date: August 18, 2022
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2022)

Lowest EtO2 value [ Time Frame: start of intubation to 2 minutes after ]

Lowest EtO2 value within the two minutes following tracheal intubation

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 9, 2022)

• 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
• 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
• Lowest SpO2 [ Time Frame: start of intubation to 2 minutes after ]
  Lowest SpO2 during intubation and within 2 min after intubation
• Highest level of EtCO2 [ Time Frame: start of intubation to 2 minutes after ]
  Highest level of EtCO2 within 2 min following intubation
• Rate of oxygen desaturation [ Time Frame: entirety of procedure ]
  Rate of oxygen desaturation below 95% during the procedure
• Number of laryngoscopy attempts [ Time Frame: before surgical procedure ]
  Number of laryngoscopy attempts before successful tracheal intubation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Surgery

Intervention

Device: Pre-oxygenation

Process of administrating oxygen prior to intubation

Study Groups/Cohorts

• 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).
  Intervention: Device: Pre-oxygenation
• 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.
  Intervention: Device: Pre-oxygenation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 9, 2022): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2025
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05495841
• Other Study ID Numbers: 2022P000396
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

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.

• Current Responsible Party: Daniel Talmor, Beth Israel Deaconess Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel S Talmor, MD; Beth Israel Deaconess Medical Center

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: December 2022