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

NCT06013098 | Completed Phase 4 DMC

• 1 other identifier: 20230724-2
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• oxygenation index

  On the operating room within 40 minutes after awakening

Study Arms (2)

Experimental: 30% Oxygen

EXPERIMENTAL

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%.

Drug: 30%Oxygen

Experimental: 60% Oxygen

PLACEBO COMPARATOR

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.

Drug: 60%Oxygen

Interventions

30%Oxygen DRUG

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

Experimental: 30% Oxygen

60%Oxygen DRUG

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

Experimental: 60% Oxygen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: September 6, 2023
• Primary Completion: January 30, 2026
• Study Completion: March 6, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CN (1)