Lung Protective Ventilation During Pulmonary Lobectomy in Children

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Seoul National University

Status

Completed

Conditions

Pulmonary Complication

Treatments

Procedure: Conventional ventilation
Procedure: lung protective ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT02680925
H1511-124-725

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

Under 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

114 participants in 2 patient groups, including a placebo group

Conventional ventilation group
Placebo Comparator group
Description:
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.
Treatment:
Procedure: Conventional ventilation
Lung protective ventilation group
Active Comparator group
Description:
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.
Treatment:
Procedure: lung protective ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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