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

NCT04008420 | Unknown

• 1 other identifier: 4-2019-0448
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation; Robotic Esophagectomy; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• The value of oxygen reserve index during anesthesia

  The investigators will monitor the oxygen reserve index during anesthesia.

  Participants will followed until discharge (within about 2 months after surgery).

Secondary Outcomes (1)

• Postoperative pulmonary complications

  Participants will followed until discharge (within about 2 months after surgery).

Study Arms (1)

Adults who are scheduled to undergo robotic esophagectomy

Adults who are scheduled to undergo robotic esophagectomy

Other: monitoring of the oxygen reserve index

Interventions

monitoring of the oxygen reserve index OTHER

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.

Adults who are scheduled to undergo robotic esophagectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults who are scheduled to undergo robotic esophagectomy

You may qualify if:

• \. Adults who are scheduled to undergo robotic esophagectomy

You may not qualify if:

• \. Patients under 20 years old
• \. Patients who can not read the consent form or are not fluent in Korean
• \. Patients who refused the clinical trial
• \. Patients admitted to the intensive care unit with endotracheal tube

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

RECRUITING

Study Officials

• So Yeon Kim, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Yeon Kim, MD

CONTACT

82-2-2228-2429; KIMSY326@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: July 31, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)