Lung CancerNCT02002273
Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial
A study testing Switching level of suction in people with Lung Cancer, run by Ospedali Riuniti Ancona at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Switching level of suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Switching level of suction
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switching level of suctionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Switching level of suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of air leak
Measured: 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
Measured: up to 5 days
Differences in fluid drainage
Measured: up to 5 days
Duration of chest tube left in the patient (days)
Measured: up to 7 days
Postoperative length of hospital stay (days)
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti Ancona
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Yale University, The University of Hong Kong
- Responsible party
- Principal investigator, Cecilia Pompili, Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002273
- Sponsor's protocol ID
- Airleak-2013-1
- Status last verified
- Mar 2016
- First submitted
- 29 Nov 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02002273
- Acronym / sponsor ID
- Airleak-2013-1
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ospedali Riuniti AnconaUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Yale University, The University of Hong Kong
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with regulated suction mode | Experimental | Procedure: Switching level of suctionOn 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. |
| regulated seal mode (-8 cmH2O). | Experimental | Procedure: Switching level of suctionOn 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Switching level of suction | Procedure or surgery | Patients with regulated suction mode, regulated seal mode (-8 cmH2O). |
Primary outcome
duration of air leak
Time frame: up to 7 days
4 secondary outcomes
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
Differences in fluid drainage
Time frame: up to 5 days
Duration of chest tube left in the patient (days)
Time frame: up to 7 days
Postoperative length of hospital stay (days)
Time frame: up to 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switching level of suction in people with Lung Cancer, run by Ospedali Riuniti Ancona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of air leak (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.