Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

Atelectasis, Postoperative Clinical Trial

— DOICA-E  

Official title:

Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013098
• Other study ID #: 20230724-2
• Status: Recruiting
• Phase: Phase 4
• Start date: September 6, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.

Description:

Therefore, we should explore the most appropriate lung protection ventilation strategy to reduce the occurrence of pulmonary complications. The recommended standard of international expert group on lung protective ventilation strategy points out that the lowest concentration of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it may reduce the postoperative pulmonary complications of the subjects. However, there are few reports on the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer. This study intends to explore the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• American Association of Anesthesiologists (ASA) patients with I-II physical condition;
• Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position.

Exclusion Criteria:

• there is a history of acute lung injury with acute respiratory distress syndrome within three months;
• Heart failure (classified by new york Heart Association) is greater than grade IV,
• there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate < 30 ml/min);
• Body mass index > 30kg/m2;
• coagulation dysfunction;
• Operation time exceeds 10h
• The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.

Related Conditions & MeSH terms

• Atelectasis, Postoperative
• Esophageal Neoplasms
• Pulmonary Atelectasis

Intervention

Drug:
• 30%Oxygen
60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation
• 60%Oxygen
100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

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	the occurrence of atelectasis	The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening	On the operating room within 40 minutes after awakening
Secondary	oxygenation index	The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis	On the operating room within 40 minutes after awakening