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

NCT ID: NCT02002273

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients with regulated suction mode

On the morning of each postoperative day (starting with POD#1) patients of group 1 are switched for 4 hours to -8 cm H2O After this period of 4 hours both groups are switched back to their original pressure levels, with the effect on air leak and fluid leak measured. Pts are then left on their original pressure level until the next day, when the switch to -8 or - 20 cm H2O is again made.

Group Type: EXPERIMENTAL

Switching level of suction

Intervention Type: PROCEDURE

regulated seal mode (-8 cmH2O).

On the morning of each postoperative day (starting with POD#1) patients of group 1 are switched for 4 hours to -8 cm H2O and patients of group 2 are switched to -20 cm H2O. After this period of 4 hours both groups are switched back to their original pressure levels, with the effect on air leak and fluid leak measured. Pts are then left on their original pressure level until the next day, when the switch to -8 or - 20 cm H2O is again made.

Group Type: EXPERIMENTAL

Switching level of suction

Intervention Type: PROCEDURE

Interventions

Switching level of suction

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Ospedali Riuniti Ancona

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Pompili

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedali Riuniti Ancona

Ancona, , Italy

Countries

Italy

Other Identifiers

Airleak-2013-1

Identifier Type: -

Identifier Source: org_study_id