The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

NCT ID: NCT02026739

Last Updated: 2014-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Oxygenation Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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low supplemental oxygen concentration

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

Group Type EXPERIMENTAL

low supplemental oxygen concentration

Intervention Type PROCEDURE

low supplemental oxygen concentration would be used during the surgery

high supplemental oxygen concentration (conventional)

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

Group Type ACTIVE_COMPARATOR

high supplemental oxygen concentration (conventional)

Intervention Type PROCEDURE

high supplemental oxygen concentration would be used during the surgery

Interventions

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low supplemental oxygen concentration

low supplemental oxygen concentration would be used during the surgery

Intervention Type PROCEDURE

high supplemental oxygen concentration (conventional)

high supplemental oxygen concentration would be used during the surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan, Lijie

OTHER

Sponsor Role lead

Responsible Party

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Tan, Lijie

Professor of Surgery; Vice Chief, Division of Thoracic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lijie Tan, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

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Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Wang, MD

Role: CONTACT

+86-21-64041990 ext. 2914

Hao Wang, MD

Role: CONTACT

Facility Contacts

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Hao Wang, MD

Role: primary

Fang Fang, MD

Role: backup

Other Identifiers

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ZSHTA2013001

Identifier Type: -

Identifier Source: org_study_id

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