Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial

Lung Cancer Clinical Trial

Official title:

The Effect of Regulated Pleural Pressure on The Duration of Air Leak and Fluid Drainage Following Pulmonary Anatomic Resections: A Multicenter Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02002273
• Other study ID #: Airleak-2013-1
• Status: Withdrawn
• Phase: N/A
• First received: November 29, 2013
• Last updated: March 28, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Ospedali Riuniti Ancona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure.

In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Able and willing to read, understand, and provide written Informed Consent;

• Age range of 18-90 years;

• Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable.

Exclusion Criteria:

• if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis

• If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis.

• If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Switching level of suction

Locations

Country	Name	City	State
Italy	Ospedali Riuniti Ancona	Ancona

Sponsors (4)

Lead Sponsor	Collaborator
Ospedali Riuniti Ancona	The Leeds Teaching Hospitals NHS Trust, The University of Hong Kong, Yale University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of air leak		up to 7 days	No
Secondary	1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups		up to 5 days	No
Secondary	Differences in fluid drainage		up to 5 days	No
Secondary	Duration of chest tube left in the patient (days)		up to 7 days	No
Secondary	Postoperative length of hospital stay (days)		up to 7 days	No