CClinicalTrials.gg
Status unknownNCT04008420Updated Jun 15, 2022

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

An observational study in Endotracheal Intubation, Robotic Esophagectomy and Esophagectomy, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Endotracheal Intubation
  • Robotic Esophagectomy
  • Esophagectomy
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults who are scheduled to undergo robotic esophagectomy

Inclusion criteria

    1. Adults who are scheduled to undergo robotic esophagectomy

Exclusion criteria

Exclusion Criteria:

    1. Patients under 20 years old
    1. Patients who can not read the consent form or are not fluent in Korean
    1. Patients who refused the clinical trial
    1. Patients admitted to the intensive care unit with endotracheal tube
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults who are scheduled to undergo robotic esophagectomy

    Adults who are scheduled to undergo robotic esophagectomy

    Other: monitoring of the oxygen reserve index

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.

06

What researchers measure

Primary outcomes

  1. The value of oxygen reserve index during anesthesia

    The investigators will monitor the oxygen reserve index during anesthesia.

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

Secondary outcomes

  1. Postoperative pulmonary complications

    The investigators will observe and record the occurrence of the postoperative pulmonary complications.

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

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    Seoul, 03722, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04008420
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
Jul 31, 2020
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Jun 15, 2022

Study contacts

So Yeon Kim, MD
Contact
KIMSY326@yuhs.ac
82-2-2228-2429
So Yeon Kim, MD
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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