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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05379673
Other study ID # IRB-63878
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 4, 2022
Est. completion date December 2025

Study information

Verified date March 2024
Source Stanford University
Contact Anthony Doufas, MD, PhD
Phone 650-498-7699
Email agdoufas@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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%).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Oxygen Gas for Inhalation
Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Apnea / hypopnea index (AHI) The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure. Ninety -minute period beginning immediately post-anesthesia.
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