Lung Protective Ventilation During Pulmonary Lobectomy in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02680925

Enrollment

114

Registered

2016-02-12

Start date

2016-02-29

Completion date

2018-02-28

Last updated

2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Complication

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.

Interventions

PROCEDURElung protective ventilation

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

PROCEDUREConventional ventilation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
The number of patients with desaturation	During surgery	The number of patients with desaturation (SpO2 \< 90%)
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026