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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013098
Acronym
DOICA-E
Enrollment
65
Registered
2023-08-28
Start date
2023-09-06
Completion date
2026-03-06
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Postoperative

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.

Interventions

DRUG30%Oxygen

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

DRUG60%Oxygen

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

Sponsors

China Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the occurrence of atelectasisOn the operating room within 40 minutes after awakeningThe primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening

Secondary

MeasureTime frameDescription
oxygenation indexOn the operating room within 40 minutes after awakeningThe 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026