Condition category
Respiratory
Date applied
20/11/2015
Date assigned
08/02/2016
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Long-term conditions which affect the lungs (chronic lung disease) and the airways are a growing problem worldwide. People with CLD are likely to experience breathlessness and chest pain, especially when exerting themselves, and so sufferers tend to avoid exercise. This can lead to their lung conditions getting worse, causing disability that is both a source of suffering and strain on the health services. Medication can be used to help improve the symptoms of CLD however it does not stop the disease from getting worse in the long term. Lung resection is an operation in which all or part of the lung is removed. Following this type of surgery, it is very important to maintain the correct pressure in the chest so that the lungs can inflate properly. This is done by placing tubes into the space around the lungs in the chest (pleural cavity) so that any air, blood, fluid or pus can drain out of the chest (chest drainage). Traditionally, the tube is attached to a system where the air or fluid “bubbles” through water inside (underwater seal). This underwater seal acts as a one-way valve and prevents the air or fluid from going back up into the pleural space. In recent years, some companies have developed chest drainage systems that contain a digital air leak meter. The aim of this study is to look at the performance of a digital chest drainage system compared to an underwater seal chest drainage system in patients who have had a pulmonary resection.

Who can participate?
Adults who have undergone a pulmonary resection.

What does the study involve?
Participants are randomly allocated to one of two groups. Following their lung resection surgery, participants in both groups have chest tubes (drains) placed into the pleural cavity, which are connected to an underwater seal drainage system. For participants in the first group (study group), the chest drainage system is connected to a digital device to monitor any air leaks. For participants in the second group, the drainage system is used alone. After the surgery, participants have a medical examination and chest x-ray every two days until they are discharged from hospital. The length of time it takes between the surgery and discharge from hospital is recorded in days for both groups.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Italy)

When is the study starting and how long is it expected to run for?
September 2010 to December 2011

Who is funding the study?
REDAX S.r.l. (Italy)

Who is the main contact?
Professor Mario Nosotti
mario.nosotti@unimi.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mario Nosotti

ORCID ID

http://orcid.org/0000-0002-8571-121X

Contact details

Via Francesco Sforza
35
Milan
20122
Italy
+39 02 5503 5570
mario.nosotti@unimi.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Digital versus analogic chest drainage in pulmonary resection

Acronym

DigiLeaks

Study hypothesis

Digital air leak evaluation should have more advantages in reducing chest drain and hospital stay after pulmonary resections.

Ethics approval

Ethics Committee Foundation IRCCS Ospedale Maggiore Policlinico of Milan Ca'Granda (Comitato Etico Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano), 18/05/, ref: 1065

Study design

Single-centre prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Pulmonary resection

Intervention

Patients are randomly allocated to one of two groups by electronic calculator.

Study group: Following lung resection surgery (pulmonary lobectomy or segmentectomy), chest tubes are connected to common water seal drainage. The drainage system is also connected to a digital device for evaluation of air leaks.

Control group: Following lung resection surgery (pulmonary lobectomy or segmentectomy), chest tubes are connected to common water seal drainage only.

Follow up for all participants consists of a daily medical examination as well as a chest x-ray every two days until discharge from hospital. One week after discharge, participants return for a repeat medical examination and chest ray. The medical examination is then repeated every 30 days until the study end (4 months after surgery).

Intervention type

Device

Phase

Drug names

Primary outcome measures

Chest tube permanence is measured by recording the days from the operation to the removal.

Secondary outcome measures

Postoperative hospital stay measured in days from time of operation until time of discharge.

Overall trial start date

01/09/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Pulmonary resection
3. Informed consent obtained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

Participant exclusion criteria

1. Patients requiring pneumonectomy
2. Patients requiring surgery for pneumothorax
3. FEV1%<70%
4. FEV1/FVC<70%
5. Hepatic or renal insufficiency
6. Systemica autoimmune diseases
7. Chronic corticosteroids treatment
8. Patients requiring lung volume reduction surgery
9. Patients requiring sleeve lobectomy

Recruitment start date

01/09/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Thioracic Surgery and lung Transplan Unit Via Francesco Sforza, 35
Milan
20122
Italy

Sponsor information

Organisation

REDAX S.r.l.

Sponsor details

Via Galileo Galilei n. 18
Poggio Rusco (MN)
46025
Italy
+390386830582
info@redax.it

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

REDAX S.r.l.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a Surgical Journal (i.e. European Journal Cardio-Thoracic Surgery).

Intention to publish date

30/11/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes