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出境医 / 临床实验 / The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy

The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Endotracheal Intubation Robotic Esophagectomy Esophagectomy Other: monitoring of the oxygen reserve index

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Adults who are scheduled to undergo robotic esophagectomy
Adults who are scheduled to undergo robotic esophagectomy
Other: monitoring of the oxygen reserve index
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.

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults who are scheduled to undergo robotic esophagectomy
Criteria

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
Contacts and Locations

Contacts
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Contact: So Yeon Kim, MD 82-2-2228-2429 KIMSY326@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: So Yeon Kim, MD    82-2-2228-2429    KIMSY326@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: So Yeon Kim, MD Severance Hospital
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 5, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date July 31, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 2, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy
Official Title The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults who are scheduled to undergo robotic esophagectomy
Condition
  • Endotracheal Intubation
  • Robotic Esophagectomy
  • Esophagectomy
Intervention Other: monitoring of the oxygen reserve index
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.
Study Groups/Cohorts Adults who are scheduled to undergo robotic esophagectomy
Adults who are scheduled to undergo robotic esophagectomy
Intervention: Other: monitoring of the oxygen reserve index
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 2, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: So Yeon Kim, MD 82-2-2228-2429 KIMSY326@yuhs.ac
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008420
Other Study ID Numbers 4-2019-0448
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators
Principal Investigator: So Yeon Kim, MD Severance Hospital
PRS Account Yonsei University
Verification Date September 2020