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RecruitingPhase 4NCT06359106

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

Sponsor

China Medical University, China

Enrollment

1,176 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

Oxygenation Index

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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
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Interventions

DRUG80% 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.

DRUG40% 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.

Locations(16)

the First Hospital of China Medical University

Shenyang, Liaoning, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Sichuan Provincial People's Hospital

Chendu, China

Chifeng Municipal Hospital

Chifeng, China

Dalian Third People's Hospital

Dalian, China

First Affiliated Hospital, Dalian Medical University

Dalian, China

First Affiliated Hospital of Harbin Medical University

Harbin, China

Harbin Medical University Cancer Hospital

Harbin, China

First Medical University and Shandong Provincial Qianfoshan Hospital

Jinan, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Affiliated Hospital of Qingdao University

Qingdao, China

Liaoning Cancer Hospital and Institute

Shenyang, China

Shenzhen People's Hospita

Shenzhen, China

First Hospital of Hebei Medical University

Shijia Zhuang, China

Second Hospital of Hebei Medical University

Shijia Zhuang, China

YANBIAN University Hospital（Yanbian Hospital）

Yanbian, China

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NCT06359106

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