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

NCT05495841 | Completed

• 1 other identifier: 2022P000396
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Lowest EtO2 value

  Lowest EtO2 value within the two minutes following tracheal intubation

  start of intubation to 2 minutes after

Secondary Outcomes (6)

• SpO2 at the start and at the end of the procedure

  start of intubation to 4 minutes after

• Tolerance of the device

  entirety of procedure

• Lowest SpO2

  start of intubation to 2 minutes after

• Highest level of EtCO2

  start of intubation to 2 minutes after

• Rate of oxygen desaturation

  entirety of procedure

Study Arms (2)

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

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

Interventions

Pre-oxygenation DEVICE

Process of administrating oxygen prior to intubation

Face Mask Alone; Face Mask and Nasal Cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 37014462 DERIVED

Study Officials

• Daniel S Talmor, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Department Chair

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 10, 2022
• Study Start: August 18, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)