- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008420
The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy
June 13, 2022 updated by: Yonsei University
The World Health Organization (WHO) has proposed the use of 80% high-dose inhalation oxygen (FiO2) during surgery to reduce postoperative infection in adult patients undergoing general anesthesia.
However, high-dose inhaled oxygen increases the risk of oxygen toxicity by increasing reactive oxygen species, and according to a recent research, hyperoxia in the ICU is one of the causes of mortality.
In patients with general anesthesia requiring intubation, high-dose inhaled oxygen was associated with postoperative pulmonary complications in a dose-proportional manner and was significantly associated with mortality within 30 days after surgery.
Therefore, it is necessary to study the optimum oxygen concentration during surgery to reduce postoperative pulmonary complications in general anesthesia patients who require intubation.
Esophagectomy for esophageal cancer still has higher morbidity and mortality rates than other common procedures.
There are several factors such as aneurysmal leakage, esophageal substitute necrosis, cardiac complications, and pulmonary complications.
Pulmonary complications have been reported to be a very important factor.
Therefore, various methods have been proposed to reduce pulmonary complications after esophageal cancer surgery.
One of them is minimally invasive surgery.
However, even in the case of a thoracoscopic operation using a robot, one lung ventilation is inevitable for securing the visual field during surgery, and hypoxia and hyperoxia are known to be associated with postoperative acute lung injury.
Therefore, in order to reduce postoperative pulmonary complications in the esophagectomy using robots, it is necessary to study the optimum oxygen concentration during surgery.
The recently developed oxygen reserve index (ORI) uses a non-invasive sensor attached to the finger, similar to pulse oximetry, to detect persistent hyperoxia of more than 100 mmHg and less than 200 mmHg.
Therefore, if the oxygen reserve index is used for robotic esophagectomy, which requires one lung ventilation, the degree of oxygenation of the patient can be monitored continuously and accurately.
The authors will measure the oxygen reserve index in robotic esophagectomy, and analyze the correlation between oxygen reserve index and postoperative pulmonary complications.
Furthermore, the cut-off value of the oxygen reserve index, which can reduce pulmonary complications, will be calculated.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: So Yeon Kim, MD
- Phone Number: 82-2-2228-2429
- Email: KIMSY326@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
-
Contact:
- So Yeon Kim, MD
- Phone Number: 82-2-2228-2429
- Email: KIMSY326@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults who are scheduled to undergo robotic esophagectomy
Description
Inclusion Criteria:
- 1. Adults who are scheduled to undergo robotic esophagectomy
Exclusion Criteria:
- 1. Patients under 20 years old
- 2. Patients who can not read the consent form or are not fluent in Korean
- 3. Patients who refused the clinical trial
- 4. Patients admitted to the intensive care unit with endotracheal tube
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults who are scheduled to undergo robotic esophagectomy
|
The investigators will enroll adult patients who will undergo robotic esophagectomy under general anesthesia.
The oxygen reserve index will be monitored continuously during anesthesia.
The postoperative complications will be recorded after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The value of oxygen reserve index during anesthesia
Time Frame: Participants will followed until discharge (within about 2 months after surgery).
|
The investigators will monitor the oxygen reserve index during anesthesia.
|
Participants will followed until discharge (within about 2 months after surgery).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pulmonary complications
Time Frame: Participants will followed until discharge (within about 2 months after surgery).
|
The investigators will observe and record the occurrence of the postoperative pulmonary complications.
|
Participants will followed until discharge (within about 2 months after surgery).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: So Yeon Kim, MD, Severance Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2020
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 2, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 4-2019-0448
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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