The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

Tan, Lijie

Status: Unknown

Conditions: Oxygenation Index

Treatments: Procedure: low supplemental oxygen concentration; Procedure: high supplemental oxygen concentration (conventional)

Study type: Interventional

Funder types: Other

Identifiers

NCT02026739

ZSHTA2013001

Details and patient eligibility

About

The study hypothesized that a relative low oxygen concentration (40%) supplemental would be advantageous to protect the pulmonary function of patients, comparied with conventional high oxygen concentration (80%). Therefore we raise this prospective randomized controlled research.

Full description

Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be randomizedly assigned to low oxygen concentration (40%) supplemental or high oxygen concentration(80%) supplemental group. Intra-operative and post-operative pressure of Oxygen in Arterial Blood will be examined, and the surgical outcome will be recorded in the two groups.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.
2. Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).

Exclusion criteria

1. Patients with previous thoracic surgery history.
2. Patients with severe Co-morbidity.
3. Pulmonary function is abnormal in the examination before surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 2 patient groups

low supplemental oxygen concentration

Experimental group

Description:

The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy.

Treatment:

Procedure: low supplemental oxygen concentration

high supplemental oxygen concentration (conventional)

Active Comparator group

Description:

The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy.

Treatment:

Procedure: high supplemental oxygen concentration (conventional)