Stanford University School of Medicine
Stanford, California, 94305, United States
Location status: Recruiting
Location contact
Anthony Doufas, MD, PhD
CONTACT
Anthony Doufas, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05379673
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
Location status: Recruiting
Anthony Doufas, MD, PhD
CONTACT
Anthony Doufas, MD, PhD
PRINCIPAL_INVESTIGATOR
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%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.
Time frame: Ninety -minute period beginning 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)
Time frame: Ninety -minute period beginning immediately post-anesthesia.
The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure.
Contact information is provided by the study sponsor or research team.
Stanford University
Other
Recovery of Ventilation After General Anesthesia for Robotic-Assisted Laparoscopic Nephrectomy or Prostatectomy: The Effect of Oxygen Supplementation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05922020
Postoperative Respiratory Failure, Respiration Disorders
Stanford, California, United States
View Trial DetailsNCT05470465
Hypercapnia, Pathological Conditions, Signs and Symptoms
West Bend, Wisconsin, United States
View Trial DetailsNCT06060626
Respiration Disorders, Respiratory Insufficiency
Prague, Czechia
View Trial DetailsNCT04310579
Hypercapnia, Pathological Conditions, Signs and Symptoms
West Bend, Wisconsin, United States
View Trial Details