Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia

January 23, 2026 updated by: Wenfei Tan, China Medical University, China
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged > 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.

Study Type

Interventional

Enrollment (Estimated)

1176

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
          • Yun Wang
      • Chendu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Qian Lei
      • Chifeng, China
        • Recruiting
        • Chifeng Municipal Hospital
        • Contact:
          • Jiannan Song
      • Dalian, China
        • Recruiting
        • Dalian Third People's Hospital
        • Contact:
          • Shiling Zhao
      • Dalian, China
        • Recruiting
        • First Affiliated Hospital, Dalian Medical University
        • Contact:
          • Yong Luan
      • Harbin, China
        • Recruiting
        • Harbin medical university cancer hospital
        • Contact:
          • Fei Han
      • Harbin, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Kun Wang
      • Jinan, China
        • Recruiting
        • First Medical University and Shandong Provincial Qianfoshan Hospital
        • Contact:
          • Jianbo Wu
      • Kunming, China
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Jianlin Shao
      • Qingdao, China
        • Recruiting
        • Affiliated Hospital of Qingdao University
        • Contact:
          • Wei Feng
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital and Institute
        • Contact:
          • Zeqing Huang
      • Shenzhen, China
        • Recruiting
        • Shenzhen People's Hospita
        • Contact:
          • Chaoran Wu
      • Shijia Zhuang, China
        • Recruiting
        • First Hospital of Hebei Medical University
        • Contact:
          • Li Wang
      • Shijia Zhuang, China
        • Recruiting
        • Second Hospital of Hebei Medical University
        • Contact:
          • Lining Huang
      • Yanbian, China
        • Recruiting
        • YANBIAN University Hospital（Yanbian Hospital）
        • Contact:
          • Yongshan Nan
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age not less than 65 years
  • American Society of Anesthesiologists grades I-III
  • No history of drug allergies or abnormal anesthesia.
  • The duration of mechanical ventilation was expected to be more than 2 hours.
  • Laparoscopic Gastrointestinal Surgery
  • The preoperative oxygen saturation was not less than 94%.
  • The patients will be planned to extubate in the operating room.

Exclusion Criteria:

  • History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
  • Cardiac function Class IV (New York Heart Association classification)
  • Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
  • Patients with blurred consciousness and cognitive dysfunction
  • Severe coagulation dysfunction.
  • Without preoperative oxygen inhalation, blood oxygen level <94%, and severe pulmonary dysfunction
  • Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.
  • Body mass index (BMI) >30kg/m2
  • Inability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control: 80% Oxygen
Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. Blood will be collected for blood gas analysis within 48 hours after surgery.
Drug: 80% Oxygen
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.
Experimental: Experimental: 40% Oxygen
Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, FiO2 will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. However, when intraoperative oxygen saturation is less than 94%, the manual lung recruitment maneuver will also be performed. Patients should transfer to 80% Oxygen group if intraoperative oxygen saturation less than 85%.Blood will be collected for blood gas analysis within 48 hours after surgery.
Drug: 40% Oxygen
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation Index
Time Frame: On the postoperative 48th hour
The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.
On the postoperative 48th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH value in blood gas analysis 48 hours after the operation
Time Frame: On the postoperative 48th hour
pH of blood gas analysis 48 hours after the operation
On the postoperative 48th hour
oxygen inhalation time
Time Frame: On the postoperative 48 hour
oxygen inhalation time
On the postoperative 48 hour
inspired oxygen concentration
Time Frame: On the postoperative 48 hour
inspired oxygen concentration
On the postoperative 48 hour
oxygen uptake rate
Time Frame: On the postoperative 48 hour
oxygen uptake rate
On the postoperative 48 hour
7 days pulmonary complications
Time Frame: On the postoperative 7th day
7 days pulmonary complications
On the postoperative 7th day
30-day Mortality
Time Frame: On the postoperative 30th day
30-day Mortality
On the postoperative 30th day
PaCO2 in blood gas analysis 48 hours after the operation
Time Frame: On the postoperative 48th hour
PaCO2 of blood gas analysis 48 hours after the operation
On the postoperative 48th hour
Lactic acid in blood gas analysis 48 hours after the operation
Time Frame: On the postoperative 48th hour
Lactic acid in blood gas analysis 48 hours after the operation
On the postoperative 48th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.3.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Statistical Analysis Plan will be published

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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