The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

Not Applicable

Recruiting

• Conditions: Postoperative Respiratory Failure; Ventilatory Depression
• Interventions: Other: Oxygen Gas for Inhalation

• Registration Number: NCT05379673
• Lead Sponsor: Stanford University

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.

Detailed Description

In a pilot randomized-controlled trial (NCT04723433) the investigators found that hyperoxia, compared with standard O2 supplementation, enhanced ventilation, as estimated by the fraction of time at a transcutaneous PCO2 (TcPCO2) \> 45 mmHg.

More specifically, patients treated with hyperoxia (O2 titrated to: SpO2 \> 96%, N=10; Liberal O2) for 90 minutes post-anesthesia, spent 61.2% of the time at TcPCO2 \> 45 mmHg, compared with 80.6% of the time in those receiving standard O2 supplementation (O2 titrated to: SpO2 between 90-94%, N=9; Conservative O2 - between-group difference of 19.4% (95% CI: -18.7% to 57.6%), ANCOVA adjusted P = 0.140\]. Results were consistent across the 90-min monitoring period. With an observed effect size of 0.73, it was estimated that 30 participants per group are required, to demonstrate this difference with a power of 80% at a two-sided alpha of 5%.

In the present confirmative randomized controlled trial, the investigators plan to estimate and compare 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) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation \> 96%) and the conservative (titrated to O2 saturation 90-94%) O2 supplementation interventions.

Hypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with more hypoventilation (i.e., more time spent with an TcPCO2 \> 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 \> 96%).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Study Start: 2022-10-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Conservative O2 Supplementation"	Oxygen Gas for Inhalation	Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
"Liberal O2 Supplementation"	Oxygen Gas for Inhalation	Oxygen administration will be titrated to an SpO2 \> 96%.

Primary Outcome Measures

Name	Time	Method
Transcutaneous partial pressure of carbon dioxide (TcPCO2)	Ninety -minute period beginning immediately post-anesthesia.	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)

Secondary Outcome Measures

Name	Time	Method
Apnea / hypopnea index (AHI)	Ninety -minute period beginning immediately post-anesthesia.	The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States