Skip to main content
OpenTrials
Completed

NCT Number: NCT06013098

Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

Therefore, we should explore the most appropriate lung protection ventilation strategy to reduce the occurrence of pulmonary complications. The recommended standard of international expert group on lung protective ventilation strategy points out that the lowest concentration of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it may reduce the postoperative pulmonary complications of the subjects. However, there are few reports on the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer. This study intends to explore the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Association of Anesthesiologists (ASA) patients with I-II physical condition;
  • Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position.

Exclusion criteria

  • there is a history of acute lung injury with acute respiratory distress syndrome within three months;
  • Heart failure (classified by new york Heart Association) is greater than grade IV,
  • there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate < 30 ml/min);
  • Body mass index > 30kg/m2;
  • coagulation dysfunction;
  • Operation time exceeds 10h
  • The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.

Treatment and study plan

30%Oxygen

Drug

60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation

60%Oxygen

Drug

100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation

Primary outcomes

  1. the occurrence of atelectasis

    Time frame: On the operating room within 40 minutes after awakening

    The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening

Secondary outcomes

  1. oxygenation index

    Time frame: On the operating room within 40 minutes after awakening

    The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Acronym: DOICA-E

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.