Protective Ventilation During Pulmonary Lobectomy

NCT ID: NCT03174743

Last Updated: 2017-06-06

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

2017-06-02

Study Completion Date

2018-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Complication Thoracic Surgery Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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%.

Group Type PLACEBO_COMPARATOR

Convential Ventilation 1

Intervention Type PROCEDURE

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

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%.

Group Type PLACEBO_COMPARATOR

Convential Ventilation 2

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Protective Ventilation 1

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Protective Ventilation 2

Intervention Type PROCEDURE

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

Interventions

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Convential Ventilation 1

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

Intervention Type PROCEDURE

Convential Ventilation 2

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

Intervention Type PROCEDURE

Protective Ventilation 1

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

Intervention Type PROCEDURE

Protective Ventilation 2

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Su Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu Su Liu, M.D/Ph.D

Role: PRINCIPAL_INVESTIGATOR

徐州医科大学附属医院医学

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Su Liu, M.D/Ph.D

Role: CONTACT

86-18118309692

Facility Contacts

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Liu Su Liu, MD/Ph.D

Role: primary

+86-18118309692

References

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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.

Reference Type RESULT
PMID: 20829341 (View on PubMed)

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.

Reference Type RESULT
PMID: 19919624 (View on PubMed)

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.

Reference Type RESULT
PMID: 23331507 (View on PubMed)

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.

Reference Type RESULT
PMID: 21436678 (View on PubMed)

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.

Reference Type RESULT
PMID: 19317902 (View on PubMed)

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.

Reference Type RESULT
PMID: 22552387 (View on PubMed)

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.

Reference Type RESULT
PMID: 22349751 (View on PubMed)

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.

Reference Type RESULT
PMID: 22934859 (View on PubMed)

Other Identifiers

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XYFY-2017-033

Identifier Type: -

Identifier Source: org_study_id

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