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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.
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Conservative O2 Supplementation" | Active Comparator | Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%. |
|
| "Liberal O2 Supplementation" | Experimental | Oxygen administration will be titrated to an SpO2 > 96%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Gas for Inhalation | Other | Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony Doufas, MD, PhD | Contact | 650-498-7699 | agdoufas@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Doufas, MD, PhD | Professor, Department of Anesthesiology, Stanford University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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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.
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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.