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

NCT ID: NCT06013098

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2026-09-30

Brief 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.

Detailed 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.

Conditions

Atelectasis, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: 30% Oxygen

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.

Group Type: EXPERIMENTAL

30%Oxygen

Intervention Type: DRUG

60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation

Experimental: 60% Oxygen

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.

Group Type: PLACEBO_COMPARATOR

60%Oxygen

Intervention Type: DRUG

100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation

Interventions

30%Oxygen

60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation

Intervention Type: DRUG

60%Oxygen

100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Wenfei Tan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wenfei Tan, M.D.,Ph.D

Role: primary

winfieldtan@hotmail.com

024-83283100

Other Identifiers

20230724-2

Identifier Type: -

Identifier Source: org_study_id