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Gas
Oxygen Gas for Inhalation for Respiratory Insufficiency
N/A
Recruiting
Led By Anthony Doufas, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ninety -minute period beginning immediately post-anesthesia.
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of oxygen on post-anesthesia recovery.
Who is the study for?
This trial is for adults in good to moderate health (ASA I-III), with a BMI under 40, who are scheduled for robotic-assisted kidney removal surgery. It's not open to those with chronic lung disease, severe brain/heart/lung conditions, major psychiatric or untreated thyroid issues, chronic pain on opioid treatment, low blood count or significant blood loss during surgery.
What is being tested?
The study tests if breathing high levels of oxygen after general anesthesia helps patients recover their normal breathing faster. Participants will be randomly assigned to receive extra oxygen or not after they wake up from anesthesia and will be monitored for 90 minutes.
What are the potential side effects?
Inhaling high levels of oxygen can sometimes cause dryness or irritation in the throat and lungs. In rare cases, prolonged exposure may lead to lung damage or changes in blood oxygen levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ninety -minute period beginning immediately post-anesthesia.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ninety -minute period beginning immediately post-anesthesia.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Transcutaneous partial pressure of carbon dioxide (TcPCO2)
Secondary study objectives
Apnea / hypopnea index (AHI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: "Liberal O2 Supplementation"Experimental Treatment1 Intervention
Oxygen administration will be titrated to an SpO2 \> 96%.
Group II: "Conservative O2 Supplementation"Active Control1 Intervention
Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,152 Total Patients Enrolled
Anthony Doufas, MD, PhDPrincipal InvestigatorProfessor, Department of Anesthesiology, Stanford University Medical School
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with severe COPD, neurological, cardiopulmonary, or psychiatric conditions, or untreated thyroid disorder.You are currently taking prescription painkillers for a long-term pain problem.Your body mass index (BMI) is below 40 kg/m2.You are planning to have a type of kidney surgery called robotic-assisted radical laparoscopic nephrectomy.
Research Study Groups:
This trial has the following groups:- Group 1: "Conservative O2 Supplementation"
- Group 2: "Liberal O2 Supplementation"
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.