Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
NCT ID: NCT06359106
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1098 participants
INTERVENTIONAL
2024-07-02
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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: 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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China Medical University, China
OTHER
Responsible Party
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Wenfei Tan
Professor,Chairman
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yun Wang
Role: primary
Qian Lei
Role: primary
Jiannan Song
Role: primary
Shiling Zhao
Role: primary
Yong Luan
Role: primary
Kun Wang
Role: primary
Fei Han
Role: primary
Jianbo Wu
Role: primary
Jianlin Shao
Role: primary
Wei Feng
Role: primary
Zeqing Huang
Role: primary
Chaoran Wu
Role: primary
Li Wang
Role: primary
Lining Huang
Role: primary
Yongshan Nan
Role: primary
Other Identifiers
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2024.3.1
Identifier Type: -
Identifier Source: org_study_id
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