Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04008420
Enrollment
100
Registered
2019-07-05
Start date
2020-07-31
Completion date
2024-06-30
Last updated
2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation, Esophagectomy, Robotic 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.

Interventions

OTHERmonitoring 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The value of oxygen reserve index during anesthesiaParticipants will followed until discharge (within about 2 months after surgery).The investigators will monitor the oxygen reserve index during anesthesia.

Secondary

MeasureTime frameDescription
Postoperative pulmonary complicationsParticipants will followed until discharge (within about 2 months after surgery).The investigators will observe and record the occurrence of the postoperative pulmonary complications.

Countries

South Korea

Contacts

Primary ContactSo Yeon Kim, MD
KIMSY326@yuhs.ac82-2-2228-2429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026