OPTiMASK: Comparison of Pre-oxygenation With Standard Face Mask Combined With High Flow Nasal Oxygen With Pre-oxygenation With Standard Face Mask Alone
NCT ID: NCT05495841
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
80 participants
OBSERVATIONAL
2022-08-18
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
Pre-oxygenation
Process of administrating oxygen prior to intubation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pre-oxygenation
Process of administrating oxygen prior to intubation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Talmor
Anesthesia Department Chair
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel S Talmor, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jaber S, De Jong A, Schaefer MS, Zhang J, Ma X, Hao X, Zhou S, Lv S, Banner-Goodspeed V, Niu X, Sfara T, Talmor D. Preoxygenation with standard facemask combining apnoeic oxygenation using high flow nasal cannula versuss standard facemask alone in patients with and without obesity: the OPTIMASK international study. Ann Intensive Care. 2023 Apr 4;13(1):26. doi: 10.1186/s13613-023-01124-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022P000396
Identifier Type: -
Identifier Source: org_study_id