Condition or disease | Intervention/treatment |
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Endotracheal Intubation Robotic Esophagectomy Esophagectomy | Other: monitoring of the oxygen reserve index |
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 |
Group/Cohort | Intervention/treatment |
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Adults who are scheduled to undergo robotic esophagectomy
Adults who are scheduled to undergo robotic esophagectomy
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: So Yeon Kim, MD | 82-2-2228-2429 | KIMSY326@yuhs.ac |
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 |
Principal Investigator: | So Yeon Kim, MD | Severance Hospital |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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.
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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 |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Adults who are scheduled to undergo robotic esophagectomy | ||||
Condition |
|
||||
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.
|
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Yonsei University | ||||
Study Sponsor | Yonsei University | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Yonsei University | ||||
Verification Date | September 2020 |