A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery

NCT ID: NCT01194895

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-03-31

Brief Summary

The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.

Detailed Description

Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.

Conditions

Acute Lung Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

protective ventilation

Group Type: EXPERIMENTAL

protective ventilation

Intervention Type: OTHER

set tidal volume of 5ml/kg during one-lung ventilation

conventional ventilation

Group Type: ACTIVE_COMPARATOR

conventional ventilation

Intervention Type: OTHER

keep tidal volume at 8ml/kg during one-lung ventilation

Interventions

protective ventilation

set tidal volume of 5ml/kg during one-lung ventilation

Intervention Type: OTHER

conventional ventilation

keep tidal volume at 8ml/kg during one-lung ventilation

Intervention Type: OTHER

Other Intervention Names

low tidal volume ventilation; normal tidal volume ventilation

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of esophageal carcinoma and planned for esophagectomy
• indication for one-lung ventilation
• informed consent
• ASA I~II

Exclusion Criteria

• NYHA III~IV
• severe COPD
• pulmonary fibrosis
• any new pulmonary infiltrate on chest radiograph
• preoperative acute infection suspected
• altered liver function( Child-Pugh class B or moe)
• acute or chronic renal failure
• preoperative corticosteroid treatment during month before inclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Zhong

department of anesthesiology and surgical intensive care unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhanggang Xue, professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

180 Fenglin Road

Shanghai, , China

Countries

China

References

Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.

Reference Type: DERIVED

PMID: 23993028 (View on PubMed)

Other Identifiers

ESOPV

Identifier Type: OTHER

Identifier Source: secondary_id

ESO-2010-LV

Identifier Type: -

Identifier Source: org_study_id