Protective Ventilation During Pulmonary Lobectomy

June 4, 2017 updated by: Su Liu, Xuzhou Medical University

The Effect of Protective Ventilation During Pulmonary Lobectomy

The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.20 Years and older 2.Patients undergoing pulmonary lobectomy

Exclusion Criteria:

  1. Emergency surgery
  2. Pulmonary hypertension
  3. Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
  4. Coagulation disorder
  5. Pulmonary or extrapulmonary infections
  6. History of treatment with steroid in 3 months before surgery
  7. History of recurrent pneumothorax
  8. History of lung resection surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Convential Ventilation 1
Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of 60%.
Procedure: Convential Ventilation 1
High tidal volume, moderate inspired oygen fraction (FiO2).
PLACEBO_COMPARATOR: Convential Ventilation 2
Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%.
Procedure: Convential Ventilation 2
High tidal volume, high inspired oygen fraction (FiO2).
ACTIVE_COMPARATOR: Protective ventilation 1
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Procedure: Protective Ventilation 1
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
ACTIVE_COMPARATOR: Protective ventilation 2
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers.
Procedure: Protective Ventilation 2
Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with pulmonary complication
Time Frame: up to postoperative 3days
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
up to postoperative 3days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2 /FiO2
Time Frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
respiratory compliance
Time Frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Dynamic compliance, Static compliance
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL6
Time Frame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL10
Time Frame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Investigators

  • Principal Investigator: Liu Su Liu, M.D/Ph.D, 徐州医科大学附属医院医学

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2017

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (ACTUAL)

June 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY-2017-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available when this trial is finished and the article have been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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