The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

Not Applicable

• Conditions: Oxygenation Index
• Interventions: Procedure: low supplemental oxygen concentration; Procedure: high supplemental oxygen concentration (conventional)

• Registration Number: NCT02026739
• Lead Sponsor: Tan, Lijie

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-31
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
low supplemental oxygen concentration	low supplemental oxygen concentration	The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy.
high supplemental oxygen concentration (conventional)	high supplemental oxygen concentration (conventional)	The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy.

Primary Outcome Measures

Name	Time	Method
The change of oxygenation index	Change from Baseline at post-operative Day1	The change of oxygenation index is an important index to indicate the pulmonary function of patients.

Trial Locations

Locations (1)

Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China