NCT03174743

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

May 30, 2017

Last Update Submit

June 4, 2017

Conditions

Pulmonary ComplicationThoracic SurgeryInflammation

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with pulmonary complication

    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 Outcomes (4)

  • PaO2 /FiO2

    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

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • IL6

    10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • IL10

    10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

Study Arms (4)

Convential Ventilation 1

PLACEBO COMPARATOR

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

Convential Ventilation 2

PLACEBO COMPARATOR

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

Protective ventilation 1

ACTIVE COMPARATOR

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

Protective ventilation 2

ACTIVE COMPARATOR

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

Interventions

Convential Ventilation 1PROCEDURE

High tidal volume, moderate inspired oygen fraction (FiO2).

Convential Ventilation 1
Convential Ventilation 2PROCEDURE

High tidal volume, high inspired oygen fraction (FiO2).

Convential Ventilation 2
Protective Ventilation 1PROCEDURE

Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.

Protective ventilation 1
Protective Ventilation 2PROCEDURE

Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.

Protective ventilation 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years and older 2.Patients undergoing pulmonary lobectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Related Publications (8)

  • Theroux MC, Fisher AO, Horner LM, Rodriguez ME, Costarino AT, Miller TL, Shaffer TH. Protective ventilation to reduce inflammatory injury from one lung ventilation in a piglet model. Paediatr Anaesth. 2010 Apr;20(4):356-64. doi: 10.1111/j.1460-9592.2009.03195.x. Epub 2009 Nov 16.

    PMID: 19919624RESULT

  • Fuller BM, Mohr NM, Drewry AM, Carpenter CR. Lower tidal volume at initiation of mechanical ventilation may reduce progression to acute respiratory distress syndrome: a systematic review. Crit Care. 2013 Jan 18;17(1):R11. doi: 10.1186/cc11936.

    PMID: 23331507RESULT

  • Kozian A, Schilling T, Schutze H, Senturk M, Hachenberg T, Hedenstierna G. Ventilatory protective strategies during thoracic surgery: effects of alveolar recruitment maneuver and low-tidal volume ventilation on lung density distribution. Anesthesiology. 2011 May;114(5):1025-35. doi: 10.1097/ALN.0b013e3182164356.

    PMID: 21436678RESULT

  • Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.

    PMID: 19317902RESULT

  • Ishikawa S. Alveolar recruitment maneuver as an important part of protective one-lung ventilation. J Anesth. 2012 Oct;26(5):794-5. doi: 10.1007/s00540-012-1396-4. Epub 2012 May 3. No abstract available.

    PMID: 22552387RESULT

  • Yang M, Ahn HJ, Kim K, Kim JA, Yi CA, Kim MJ, Kim HJ. Does a protective ventilation strategy reduce the risk of pulmonary complications after lung cancer surgery?: a randomized controlled trial. Chest. 2011 Mar;139(3):530-537. doi: 10.1378/chest.09-2293. Epub 2010 Sep 9.

    PMID: 20829341RESULT

  • Kim SH, Jung KT, An TH. Effects of tidal volume and PEEP on arterial blood gases and pulmonary mechanics during one-lung ventilation. J Anesth. 2012 Aug;26(4):568-73. doi: 10.1007/s00540-012-1348-z. Epub 2012 Feb 18.

    PMID: 22349751RESULT

  • Ahn HJ, Kim JA, Yang M, Shim WS, Park KJ, Lee JJ. Comparison between conventional and protective one-lung ventilation for ventilator-assisted thoracic surgery. Anaesth Intensive Care. 2012 Sep;40(5):780-8. doi: 10.1177/0310057X1204000505.

    PMID: 22934859RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Liu Su Liu, M.D/Ph.D

    徐州医科大学附属医院医学

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Su Liu, M.D/Ph.D

CONTACT

86-18118309692xyfymzk@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

June 2, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(1)