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Recruiting NCT06359106

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

Phase IV Interventional Oxygenation Index

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 80% Oxygen, 40% Oxygen.
Who it may be relevant to
Registry conditions: Oxygenation Index. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Oxygenation Index [Time frame: On the postoperative 48th hour]
Secondary outcome measures (8)
  • pH value in blood gas analysis 48 hours after the operation [Time frame: On the postoperative 48th hour]
  • oxygen inhalation time [Time frame: On the postoperative 48 hour]
  • inspired oxygen concentration [Time frame: On the postoperative 48 hour]
  • oxygen uptake rate [Time frame: On the postoperative 48 hour]
  • 7 days pulmonary complications [Time frame: On the postoperative 7th day]
  • 30-day Mortality [Time frame: On the postoperative 30th day]
  • PaCO2 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 [Time frame: On the postoperative 48th hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 16 centers
  • the First Hospital of China Medical University — Shenyang
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Sichuan Provincial People's Hospital — Chendu
  • Chifeng Municipal Hospital — Chifeng
  • Dalian Third People's Hospital — Dalian
  • First Affiliated Hospital, Dalian Medical University — Dalian
  • First Affiliated Hospital of Harbin Medical University — Harbin
  • Harbin Medical University Cancer Hospital — Harbin
  • … and 8 more centers

Publications

  • 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; PMID 41572351

Identifiers

NCT: NCT06359106 · 2024.3.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗