Hyperoxia on Ventilation During Recovery From General Anesthesia

NCT05922020 | Completed

• 1 other identifier: IRB-70628
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this preliminary, crossover investigation the investigators will examine the effect of oxygen supplementation on the recovery of breathing in the immediate post-anesthesia period.

Conditions

Ventilatory Depression; Postoperative Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• Respiratory disturbance index (RDI)

  The number of apnea/hypopnea episodes detected using respiratory inductance plethysmography and nasal flow.

  Forty minutes of monitoring for each treatment arm

• Transcutaneous carbon dioxide pressure (TcPCO2)

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

  Forty minutes of monitoring for each treatment arm

Study Arms (2)

"Conservative O2"

ACTIVE COMPARATOR

During the first treatment session, which will last for 40 minutes, O2 supplementation will be titrated to an SpO2 between 90% and 94%.

Other: Oxygen gas

"Liberal O2"

EXPERIMENTAL

During the second treatment session, which will last for 40 minutes, O2 supplementation will be titrated to an SpO2 \> 96%.

Other: Oxygen gas

Interventions

Oxygen gas OTHER

Administration of Oxygen by inhalation

"Conservative O2"; "Liberal O2"

Eligibility Criteria

• Age: 20 Years - 90 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 35 kg/m2
• Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy.

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

Location

Related Publications (1)

• Kutscher S, Finnsson E, Tian L, Panousis P, Chung BI, Doufas AG. The effect of hyperoxia on disordered breathing during recovery from general anesthesia: A single-blinded, crossover, non-randomized -controlled, trial. J Clin Anesth. 2026 Jan;108:112057. doi: 10.1016/j.jclinane.2025.112057. Epub 2025 Oct 31.

  PMID: 41175776 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

nitrox

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Anthony Doufas, MD, PhD

  Professor, Department of Anesthesiology, Stanford University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 1. Study participants will not be aware of the inspired O2 concentration in their breathing gas mixture. All participants will be breathing through a non-rebreather mask, which will be connected via a Y -piece to both the O2 and air wall outlets. 2. The investigator who will regulating the O2 inspired concentration-related intervention, will be blinded to the continuous TcPCO2 measurement. In addition, the sleep medicine specialist who will assess the breathing pattern offline and score the number and nature of apnea/hypopnea episodes, will also be blinded to the treatment arm.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Model Details: With the patients' admission to the post-anesthesia care unit and after a 20-minute-long stabilization period, two 40-minute-long treatment sessions will be applied to the study patients. In the first 6 patients Conservative O2 treatment will be applied first, whereas in the rest (patients 7-10) the order of the interventions will be reversed. The order of the interventions will not be revealed to the participants before completing the study. In the Conservative O2 treatment session, O2 supplementation will be titrated to an SpO2 between 90% and 94%, while in the Liberal O2, O2 administration will be titrated to an SpO2 \> 96%.

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 28, 2023
• Study Start: August 8, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)