ClinicalTrials.gg
RecruitingNCT05379673Updated Sep 24, 2026

The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

An interventional study of Oxygen Gas for Inhalation in Ventilatory Depression and Postoperative Respiratory Failure, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 349 studies in Respiratory Insufficiency with a site in United States — 44 open to participants now, 61 under way, 1 of them phase 3. Respiratory Insufficiency · United States.

Planned enrollment
103rd of 253
60 · median 42
Started
2022
with 13 others
No phase
159 of 349
30 open now
Primary completion
2026-12
later than 23 of 60 live
Registered
283rd of 349
by date

Among the 349 studies in Respiratory Insufficiency with a site in United States, this one is the 103rd largest by planned enrollment of the 253 interventional ones, is one of 14 that started in 2022, is one of 159 with no phase, reaches primary completion later than 23 of the 60 other live ones, and was the 283rd registered.

By phase

349 studies; the count open now beside each. This study's row is marked.

No phasethis study159 · 30 open
Observational95 · 9 open
Phase 228 · 3 open
Phase 123 · 0 open
Phase 321 · 1 open
Phase 49 · 1 open
Phase 1/28 · 0 open
Phase 2/36 · 0 open

By the year they started

First in 1992; this study’s year is marked. 14 started in 2022.

Size and results

Median enrollment 42 across the 253 interventional studies, 65 across the 95 observational. Of the 245 that completed or were terminated, 93 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 349 studies in Respiratory Insufficiency with a site in United States, or all of them as a file.
02

Study 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.

Read the 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%).

03

Conditions studied

  • Ventilatory Depression
  • Postoperative Respiratory Failure
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (ASA) physical status I-III
  • (BMI) less than 40 kg/m2
  • Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy or prostatectomy.

Exclusion criteria

Exclusion Criteria:

  • Patients with a diagnosis of chronic obstructive pulmonary disorder (), 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    "Conservative O2 Supplementation"

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

    Other: Oxygen Gas for Inhalation

  • Experimental
    "Liberal O2 Supplementation"

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

    Other: Oxygen Gas for Inhalation

Interventions

  • OtherOxygen Gas for Inhalation

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Ninety -minute period beginning immediately post-anesthesia.

Secondary outcomes

  1. Apnea / hypopnea index (AHI)

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

    Time frame: Ninety -minute period beginning immediately post-anesthesia.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Dec 2026, 50 months after the start.

Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 50 months is above that.

Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2022
First posted
May 18, 2022
StartActual
Oct 4, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05379673
Responsible party
Anthony Doufas (Professor, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University) — Principal investigator
First posted
May 18, 2022
Start date
Oct 4, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

Anthony Doufas, MD, PhD
Contact
agdoufas@stanford.edu
650-498-7699
Anthony Doufas, MD, PhD
principal investigator · Professor, Department of Anesthesiology, Stanford University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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