Recruiting

Hyperoxia

Sponsor:

Stanford University

Code:

NCT05379673

Conditions

Ventilatory Depression

Postoperative Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Oxygen Gas for Inhalation

Study Details

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

Study ID

NCT05379673

Start date

Oct 4, 2022

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: "Conservative O2 Supplementation"

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

experimental: "Liberal O2 Supplementation"

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

Interventions

Oxygen Gas for Inhalation

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

Primary outcome measure

  • Transcutaneous partial pressure of carbon dioxide (TcPCO2) [ Time Frame: Ninety -minute period beginning immediately post-anesthesia. ]

Central Contacts and Locations

Central contacts

Anthony Doufas, MD, PhD

650-498-7699agdoufas@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Anthony Doufas, MD, PhD

(650) 498-7699agdoufas@stanford.edu

Principal Investigator:

Anthony Doufas, MD, PhD

More Information

Sponsor

Stanford University

Last update posted

May 16, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-16.