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

NCT02002273 | Withdrawn

• 1 other identifier: Airleak-2013-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• duration of air leak

  up to 7 days

Secondary Outcomes (4)

• 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

• Differences in fluid drainage

  up to 5 days

• Duration of chest tube left in the patient (days)

  up to 7 days

• Postoperative length of hospital stay (days)

  up to 7 days

Study Arms (2)

Patients with regulated suction mode

EXPERIMENTAL

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.

Procedure: Switching level of suction

regulated seal mode (-8 cmH2O).

EXPERIMENTAL

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.

Procedure: Switching level of suction

Interventions

Switching level of suction PROCEDURE

Patients with regulated suction mode; regulated seal mode (-8 cmH2O).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedali Riuniti Ancona: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Yale University: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Ospedali Riuniti Ancona

Ancona, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

IT (1)