Your session is about to expire
← Back to Search
Other
High vs Low Oxygen Levels for Lung Injury
N/A
Waitlist Available
Led By Jiapeng Huang, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age from 18 to 75
Undergoing isolated selective on-pump CABG through median sternotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one week while in the hospital
Awards & highlights
Study Summary
This trial will study the effects of different levels of oxygen given during surgery on post-operative pulmonary complications and lung injury.
Who is the study for?
This trial is for adults aged 18-75 with a BMI of 20-39.9, classified as ASA II/III, who are undergoing on-pump coronary artery bypass grafting (CABG) surgery via median sternotomy and will be admitted to ICU post-surgery. Excluded are those with severe COPD, pregnant women, recent acute coronary syndrome or anemia, pre-op oxygen needs for arterial O2 maintenance at 92%, heart shunts or carotid stenosis over 50%, certain cardiac surgeries, dialysis users, recent smokers and some other specific conditions.Check my eligibility
What is being tested?
The study tests the effects of different levels of inspired oxygen (FiO2) given during surgery on lung injury and pulmonary complications after CABG surgery. It's observer-blinded meaning the observers don't know which treatment participants receive; it uses central randomization to decide who gets what level of FiO2 in multiple centers.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include respiratory issues due to varying oxygen levels during operation which could affect lung function post-surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am having a specific heart bypass surgery through a chest cut while on a heart-lung machine.
Select...
I have been admitted to the ICU recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48hr post operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48hr post operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
arterial PO2/FiO2 Ratio
Secondary outcome measures
Pulmonary complications
length of hospital stay
length of mechanical ventilation
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Restrictive OxygenExperimental Treatment1 Intervention
The restrictive oxygen patients' Fraction of Inspired Oxygen (FiO2) will be set at a minimum of 0.3 to maintain their oxygen saturations (SpO2) greater than or equal to 95% intraoperatively. During CPB a blended air/oxygen mixture will be titrated to arterial blood gas analysis with aim of maintenance of PaO2 between 100 and 150 mmHg. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation.
Group II: Liberal OxygenActive Control1 Intervention
The liberal oxygen group will consist of subjects exposed to a Fraction of Inspired Oxygen (FiO2) set at 1.0 throughout the intraoperative period, including during cardiopulmonary bypass. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation.
Find a Location
Who is running the clinical trial?
Peking University People's HospitalOTHER
569 Previous Clinical Trials
6,456,081 Total Patients Enrolled
Guangdong Provincial People's HospitalOTHER
312 Previous Clinical Trials
1,936,175 Total Patients Enrolled
Second Xiangya Hospital of Central South UniversityOTHER
89 Previous Clinical Trials
237,196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have smoked within the last month.Your body mass index (BMI) is between 20 and 39.9.I have received a blood transfusion during surgery.I needed a breathing tube reinserted for reasons not related to my lungs, like bleeding or heart failure.I need extra oxygen before surgery to keep my blood oxygen level above 92%.I have severe COPD.I have had a heart attack or severe chest pain within the last week.I need heart surgery that involves stopping my circulation.You have a specific heart condition where blood can flow from the right side to the left side of the heart.You have very low levels of hemoglobin in your blood.You have a blockage of more than 50% in either of your carotid arteries.I am currently undergoing dialysis.I will be on one-lung ventilation during my surgery.I am between 18 and 75 years old.I am having a specific heart bypass surgery through a chest cut while on a heart-lung machine.I have been admitted to the ICU recently.You have moderate to severe health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Restrictive Oxygen
- Group 2: Liberal Oxygen
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research protocol accept participants aged 35 and above?
"The eligibility for this study necessitates that enrollees are between 18 and 75 years old. There are 133 investigations with participants below the age of majority, while 607 have those over 65."
Answered by AI
Is enrollment for this research project still open?
"This investigation, posted on December 1st 2023 and last updated November 13th 2022 is not currently searching for participants. Nonetheless, there are 767 other clinical studies actively recruiting now."
Answered by AI
Who is eligible to take part in this clinical experiment?
"This trial is open to 160 individuals with pulmonary damage aged between 18 and 75. The criteria for applicant eligibility include: a range of ages from 18-75, body mass index scores ranging from 20 to 39.9, American Society of Anesthesiologists physical status class II or III classification, isolated selective on-pump coronary artery bypass grafting conducted via median sternotomy surgery, and subsequent admission into an intensive care unit (ICU)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger