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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002273
Recruitment Status : Withdrawn
First Posted : December 5, 2013
Last Update Posted : March 29, 2016
Sponsor:
Collaborators:
The Leeds Teaching Hospitals NHS Trust
Yale University
The University of Hong Kong
Information provided by (Responsible Party):
Cecilia Pompili, Ospedali Riuniti Ancona

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Switching level of suction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Switching level of suction
Experimental: 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.
Procedure: Switching level of suction



Primary Outcome Measures :
  1. duration of air leak [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: up to 5 days ]
  2. Differences in fluid drainage [ Time Frame: up to 5 days ]
  3. Duration of chest tube left in the patient (days) [ Time Frame: up to 7 days ]
  4. Postoperative length of hospital stay (days) [ Time Frame: up to 7 days ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002273


Locations
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Italy
Ospedali Riuniti Ancona
Ancona, Italy
Sponsors and Collaborators
Ospedali Riuniti Ancona
The Leeds Teaching Hospitals NHS Trust
Yale University
The University of Hong Kong
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Responsible Party: Cecilia Pompili, MD, Ospedali Riuniti Ancona
ClinicalTrials.gov Identifier: NCT02002273    
Other Study ID Numbers: Airleak-2013-1
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016