Skip to main content
OpenTrials
Completed

NCT Number: NCT02680925

Lung Protective Ventilation During Pulmonary Lobectomy in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Complication

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

conventional ventilation

Procedure

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

Primary outcomes

  1. The number of patients with pulmonary complication

    Time frame: 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 outcomes

  1. The number of patients with desaturation

    Time frame: During surgery

    The number of patients with desaturation (SpO2 < 90%)

  2. The number of patients with extrapulmonary complication

    Time frame: through study completion, an average of 1 year

  3. Mean duration of mechanical ventilation

    Time frame: through study completion, an average of 1 year

  4. Mean duration of ICU stay

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2016
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.