Lung Protective Ventilation During Pulmonary Lobectomy in Children

NCT02680925 | Completed DMC

• 1 other identifier: H1511-124-725
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Complication

Outcome Measures

Primary Outcomes (1)

• The number 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 7 days

Secondary Outcomes (4)

• The number of patients with desaturation

  During surgery

• The number of patients with extrapulmonary complication

  through study completion, an average of 1 year

• Mean duration of mechanical ventilation

  through study completion, an average of 1 year

• Mean duration of ICU stay

  through study completion, an average of 1 year

Study Arms (2)

Conventional ventilation group

PLACEBO COMPARATOR

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.

Procedure: Conventional ventilation

Lung protective ventilation group

ACTIVE COMPARATOR

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.

Procedure: lung protective ventilation

Interventions

lung protective ventilation PROCEDURE

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

Lung protective ventilation group

Conventional ventilation PROCEDURE

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

Conventional ventilation group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• History of airway or pulmonary interstitial disease
• Active URI
• Systemic inflammatory response disease
• cardiac disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30916035 DERIVED

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: Associate professor

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)