Lung Protective Ventilation During Pulmonary Lobectomy in Children

Not Applicable

Completed

• Conditions: Pulmonary Complication
• Interventions: Procedure: Conventional ventilation; Procedure: lung protective ventilation

• Registration Number: NCT02680925
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-06
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-12
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ventilation group	Conventional ventilation	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.
Lung protective ventilation group	lung protective ventilation	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.

Primary Outcome Measures

Name	Time	Method
The number of patients with pulmonary complication	up to postoperative 7 days	The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism

Secondary Outcome Measures

Name	Time	Method
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
The number of patients with desaturation	During surgery	The number of patients with desaturation (SpO2 \< 90%)
Mean duration of ICU stay	through study completion, an average of 1 year

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of