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NCT Number: NCT06359106

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University, Shenyang, Liaoning, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. oxygen inhalation time

    Time frame: On the postoperative 48 hour

    oxygen inhalation time

  3. inspired oxygen concentration

    Time frame: On the postoperative 48 hour

    inspired oxygen concentration

  4. oxygen uptake rate

    Time frame: On the postoperative 48 hour

    oxygen uptake rate

  5. 7 days pulmonary complications

    Time frame: On the postoperative 7th day

    7 days pulmonary complications

  6. 30-day Mortality

    Time frame: On the postoperative 30th day

    30-day Mortality

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tianhao Zhang, M.D.

CONTACT

[email protected]

+862483283100

Yang An, M.D.

CONTACT

[email protected]

+862483283100

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Jan 26, 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.

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