The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

NCT05379673 | Recruiting

• 1 other identifier: IRB-63878
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized-controlled trial the investigators will examine the effect of oxygen supplementation on the recovery of breathing for 90 minutes in the immediate post-anesthesia period starting from extubation of the trachea.

Conditions

Ventilatory Depression; Postoperative Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Transcutaneous partial pressure of carbon dioxide (TcPCO2)

  The cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide (TcPCO2: primary outcome) will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \> 45 mmHg)

  Ninety -minute period beginning immediately post-anesthesia.

Secondary Outcomes (1)

• Apnea / hypopnea index (AHI)

  Ninety -minute period beginning immediately post-anesthesia.

Study Arms (2)

"Conservative O2 Supplementation"

ACTIVE COMPARATOR

Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.

Other: Oxygen Gas for Inhalation

"Liberal O2 Supplementation"

EXPERIMENTAL

Oxygen administration will be titrated to an SpO2 \> 96%.

Other: Oxygen Gas for Inhalation

Interventions

Oxygen Gas for Inhalation OTHER

Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.

"Conservative O2 Supplementation"; "Liberal O2 Supplementation"

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III
• Body mass index (BMI) less than 40 kg/m2
• Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy or prostatectomy.

You may not qualify if:

• Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder
• Chronic pain condition that is being treated with opioids
• Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during surgery.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Anthony Doufas, MD, PhD

  Professor, Department of Anesthesiology, Stanford University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Doufas, MD, PhD

CONTACT

650-498-7699; agdoufas@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the received treatment. The investigators, who will monitor the patients and collect the data in the PACU, will be blinded to the primary outcome, but not to the received treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Model Details: In the post-anesthesia care unit (PACU), participants will be randomized to receive conservative (titrated to an SpO2 between 90 and 94%) versus liberal (titrated to SpO2 \> 96%) oxygen supplementation, via a non-rebreather mask.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)