The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026739

Enrollment

120

Registered

2014-01-03

Start date

2013-09-30

Completion date

2014-07-31

Last updated

2014-01-03

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

Conditions

Oxygenation Index

Keywords

minimally invasive esophagectomy; pulmonary function

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.

Interventions

PROCEDURElow supplemental oxygen concentration

low supplemental oxygen concentration would be used during the surgery

PROCEDUREhigh supplemental oxygen concentration (conventional)

high supplemental oxygen concentration would be used during the surgery

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHao Wang, MD

wang.hao@zs-hospital.sh.cn+86-21-64041990

Backup ContactHao Wang, MD

wanghao6611@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026