Lung Protective Ventilation During Pulmonary Lobectomy in Children

Pulmonary Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680925
• Other study ID #: H1511-124-725
• Status: Completed
• Phase: N/A
• First received: February 6, 2016
• Last updated: March 5, 2018
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Complication

Intervention

Procedure:
• lung protective ventilation
TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O
• Conventional ventilation
TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of patients with desaturation	The number of patients with desaturation (SpO2 < 90%)	During surgery
Secondary	The number of patients with extrapulmonary complication		through study completion, an average of 1 year
Secondary	Mean duration of mechanical ventilation		through study completion, an average of 1 year
Secondary	Mean duration of ICU stay		through study completion, an average of 1 year