Ventilatory DepressionNCT04723433
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy
A study testing Oxygen gas -Conservative and Oxygen gas -Liberal in people with Ventilatory Depression and Postoperative Respiratory Complication, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilatory Depression, Postoperative Respiratory Complication
- What is being tested?
- Oxygen gas -Conservative and Oxygen gas -Liberal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 their surgery, will be also excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.
Read the detailed description
The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.
In this feasibility 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 less hypoventilation (i.e., less time spent with an TcPCO2 > 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).
- Being tested
- Oxygen gas -Conservative, Oxygen gas -Liberal
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen gas -ConservativeOther
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.
Oxygen gas -LiberalOther
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.
| Study group | Role | What they receive |
|---|---|---|
| "Conservative O2 Supplementation" | Experimental | Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%. Receives: Other: Oxygen gas -Conservative |
| "Liberal O2 Supplementation" | Active comparator | Oxygen administration will titrated to an SpO2 > 96%. Receives: Other: Oxygen gas -Liberal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Ninety -minute period immediately post-anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Feb 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilatory DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Doufas, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723433
- Sponsor's protocol ID
- IRB-59593
- Status last verified
- Sep 2021
- First submitted
- 21 Jan 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doufas AG, Tian L, Kutscher S, Finnsson E, Agustsson JS, Chung BI, Panousis P. The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial. J Clin Anesth. 2022 Dec;83:110982. doi: 10.1016/j.jclinane.2022.110982. Epub 2022 Oct 17.
PubMed 36265267
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study
- ClinicalTrials.gov ID
- NCT04723433
- Acronym / sponsor ID
- IRB-59593
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.
Detailed description
The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.
In this feasibility 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 less hypoventilation (i.e., less time spent with an TcPCO2 > 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| "Conservative O2 Supplementation" | Experimental | Other: Oxygen gas -ConservativeOxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%. |
| "Liberal O2 Supplementation" | Active comparator | Other: Oxygen gas -LiberalOxygen administration will titrated to an SpO2 > 96%. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 their surgery, will be also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen gas -ConservativeOxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%. | Other | "Conservative O2 Supplementation" |
| Oxygen gas -LiberalOxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%. | Other | "Liberal O2 Supplementation" |
Primary outcome
Transcutaneous partial pressure of carbon dioxide (TcPCO2)
Time frame: Ninety -minute period 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 36265267Doufas AG, Tian L, Kutscher S, Finnsson E, Agustsson JS, Chung BI, Panousis P. The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial. J Clin Anesth. 2022 Dec;83:110982. doi: 10.1016/j.jclinane.2022.110982. Epub 2022 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen gas -Conservative and Oxygen gas -Liberal in people with Ventilatory Depression and Postoperative Respiratory Complication, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous partial pressure of carbon dioxide (TcPCO2) (time frame: Ninety -minute period immediately post-anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.