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

Oxygenation Index Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359106
• Other study ID #: 2024.3.1
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: China Medical University, China
• Contact: Tianhao Zhang, M.D.
• Phone: +862483283100
• Email: zhth774176947[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1098
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oxygenation Index

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Sichuan Provincial People's Hospital	Chendu
China	Chifeng Municipal Hospital	Chifeng
China	First Affiliated Hospital of Chongqing Medical University	Chongqi
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 Hospital, Jilin University	Jilin
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan
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	Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Liaoning Cancer Hospital and Institute	Shenyang
China	the First Hospital of China Medical University	Shenyang	Liaoning
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	Tianjin Fifth Central Hospital	Tianjin
China	YANBIAN University Hospital(Yanbian Hospital)	Yanbian

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pH value in blood gas analysis 48 hours after the operation	pH of blood gas analysis 48 hours after the operation	On the postoperative 48th hour
Secondary	oxygen inhalation time	oxygen inhalation time	On the postoperative 48 hour
Secondary	inspired oxygen concentration	inspired oxygen concentration	On the postoperative 48 hour
Secondary	oxygen uptake rate	oxygen uptake rate	On the postoperative 48 hour
Secondary	7 days pulmonary complications	7 days pulmonary complications	On the postoperative 7th day
Secondary	30-day Mortality	30-day Mortality	On the postoperative 30th day
Secondary	PaCO2 in blood gas analysis 48 hours after the operation	PaCO2 of blood gas analysis 48 hours after the operation	On the postoperative 48th hour
Secondary	Lactic acid in blood gas analysis 48 hours after the operation	Lactic acid in blood gas analysis 48 hours after the operation	On the postoperative 48th hour