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

NCT06359106 | Recruiting Phase 4 DMC

• 1 other identifier: 2024.3.1
• Study Type: interventional
• Target: 1,176
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Oxygenation Index

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index

  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 Outcomes (8)

• pH value in blood gas analysis 48 hours after the operation

  On the postoperative 48th hour

• oxygen inhalation time

  On the postoperative 48 hour

• inspired oxygen concentration

  On the postoperative 48 hour

• oxygen uptake rate

  On the postoperative 48 hour

• 7 days pulmonary complications

  On the postoperative 7th day

Study Arms (2)

Control: 80% Oxygen

PLACEBO COMPARATOR

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

Experimental: 40% Oxygen

EXPERIMENTAL

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

Interventions

40% Oxygen DRUG

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.

Experimental: 40% Oxygen

80% Oxygen DRUG

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.

Control: 80% Oxygen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (16)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

Sichuan Provincial People's Hospital

Chendu, China

RECRUITING

Chifeng Municipal Hospital

Chifeng, China

RECRUITING

Dalian Third People's Hospital

Dalian, China

RECRUITING

First Affiliated Hospital, Dalian Medical University

Dalian, China

RECRUITING

First Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, China

RECRUITING

First Medical University and Shandong Provincial Qianfoshan Hospital

Jinan, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, China

RECRUITING

Shenzhen People's Hospita

Shenzhen, China

RECRUITING

First Hospital of Hebei Medical University

Shijia Zhuang, China

RECRUITING

Second Hospital of Hebei Medical University

Shijia Zhuang, China

RECRUITING

YANBIAN University Hospital（Yanbian Hospital）

Yanbian, China

RECRUITING

Related Publications (1)

• Zhang T, An Y, Zhao S, Han F, Huang L, Wang L, Wu J, Lei Q, Wang K, Shao J, Wang Y, Luan Y, Feng W, Song J, Huang Z, Wu C, Nan Y, Tang B, Sun X, Tan W. Effects of varying inhaled oxygen concentrations on lung function in older adult patients undergoing laparoscopic gastrointestinal surgery under general anesthesia: protocol of a prospective multicenter clinical study in China. Trials. 2026 Jan 23;27(1):139. doi: 10.1186/s13063-026-09471-3.

  PMID: 41572351 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

Tianhao Zhang, M.D.

CONTACT

+862483283100; zhth774176947@163.com

Yang An, M.D.

CONTACT

+862483283100; cmu_ay2016@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Chairman

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (16)