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The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

Primary Purpose

Ventilatory Depression, Postoperative Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen Gas for Inhalation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilatory Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

"Conservative O2 Supplementation"

"Liberal O2 Supplementation"

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Apnea / hypopnea index (AHI)
The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure.

Full Information

First Posted
May 12, 2022
Last Updated
October 17, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05379673
Brief Title
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Official Title
Recovery of Ventilation After General Anesthesia for Robotic-Assisted Laparoscopic Nephrectomy: The Effect of Oxygen Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Depression, Postoperative Respiratory Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Conservative O2 Supplementation"
Arm Type
Active Comparator
Arm Description
Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
Arm Title
"Liberal O2 Supplementation"
Arm Type
Experimental
Arm Description
Oxygen administration will be titrated to an SpO2 > 96%.
Intervention Type
Other
Intervention Name(s)
Oxygen Gas for Inhalation
Intervention Description
Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.
Primary Outcome Measure Information:
Title
Transcutaneous partial pressure of carbon dioxide (TcPCO2)
Description
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)
Time Frame
Ninety -minute period beginning immediately post-anesthesia.
Secondary Outcome Measure Information:
Title
Apnea / hypopnea index (AHI)
Description
The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure.
Time Frame
Ninety -minute period beginning immediately post-anesthesia.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Doufas, MD, PhD
Phone
650-498-7699
Email
agdoufas@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Doufas, MD, PhD
Organizational Affiliation
Professor, Department of Anesthesiology, Stanford University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Doufas, MD, PhD
Phone
650-498-7699
Email
agdoufas@stanford.edu
First Name & Middle Initial & Last Name & Degree
Anthony Doufas, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

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