Lung Protective Ventilation During Pulmonary Lobectomy in Children

NCT ID: NCT02680925

Last Updated: 2018-03-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-02-28

Brief Summary

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The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.

Detailed Description

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Conditions

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Pulmonary Complication

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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Conventional ventilation group

Mechanical ventilation is maintained with tidal volume (TV) of 10 ml/kg without PEEP during two-lung ventilation and TV of 8 ml/kg without PEEP during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection.

Group Type PLACEBO_COMPARATOR

Conventional ventilation

Intervention Type PROCEDURE

TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP

Lung protective ventilation group

Mechanical ventilation is maintained with tidal volume (TV) of 6 ml/kg with PEEP 6 cmH2O during two-lung ventilation and TV of 4 ml/kg PEEP 6 cmH2O during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection.

Group Type ACTIVE_COMPARATOR

lung protective ventilation

Intervention Type PROCEDURE

TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O

Interventions

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lung protective ventilation

TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O

Intervention Type PROCEDURE

Conventional ventilation

TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children who are scheduled for lung lobectomy under general anesthesia
* ASA physical status I, II

Exclusion Criteria

* History of airway or pulmonary interstitial disease
* Active URI
* Systemic inflammatory response disease
* cardiac disease
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.

Reference Type DERIVED
PMID: 30916035 (View on PubMed)

Other Identifiers

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H1511-124-725

Identifier Type: -

Identifier Source: org_study_id

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