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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 January 2020 |
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Main ID: |
ISRCTN10408356 |
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Date of registration:
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13/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mobile drainage with high suction versus mobile drainage with low suction.
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Scientific title:
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The influence of suction on chest drain duration and fluid output after lobectomy using only electronic chest drainage systems – a randomized clinical trial |
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Date of first enrolment:
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03/03/2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN10408356 |
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Study type:
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Interventional |
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Study design:
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Single-center randomized study (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Marike
Lijkendijk |
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Address:
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Department of Cardiothoracic and Vascular Surgery
Odense University Hospital
J.B. Winsløws Vej 4
5000
Odense
Denmark |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Admitted for lobectomy (by thoracotomy or video-assisted thoracoscopic
surgery [VATS] as decided by the surgeon)
2. Aged over 18 years
3. Ability to give informed consent
Exclusion criteria:
1. Previous history of pulmonary or cardiac surgery
2. Expected difficulties with postoperative mobilization
3. Participation in concomitant research studies in our department in which a different chest drainage protocol could influence these results
4. Anticipation of a need for postoperative mechanical ventilation
5. Insertion of more than one chest drain
6. Bilobectomy or middle lobectomy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary lobectomy
Surgery
Pulmonary lobectomy
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Intervention(s)
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Following pulmonary lobectomy (lower or upper lobes) patients are randomly assigned (1:1) by sequentially numbered, opaque, and sealed envelopes to one of two groups. Participants receive either low external suction (–5 cm H2O) or high external suction (–20 cm H2O) via a size 24 French silicone chest drain connected to an electronic drainage device. All other postoperative care is the same in both groups.
Treatment ends when the chest drains are removed. Both arms use a chest drainage removal algorithm; patients have to be well pain managed and mobilized. There is no upper limit on fluid output (providing it is serous and no chylous). Air leak is < 20 ml/min with no spikes for 6 hours or < 50 ml/min with no spikes for 12 hours.
Participants are followed up in the outpatient clinic two weeks after discharge from hospital.
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Primary Outcome(s)
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Duration of air leakage is measured using the time of end of surgery and the time when the chest drain was removed (information from electronic patient charts).
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Secondary Outcome(s)
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1. Fluid output is measured by recording measurements from the drainage device cannister on the patient chart.
2. Length of stay is recorded from hospital records.
3. Re-insertion of chest drains (complications) is recorded using the information from the patient chart.
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Secondary ID(s)
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Thopaz 2.0
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Source(s) of Monetary Support
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Odense Universitetshospital
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Ethics review
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Status:
Approval date:
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Ethics approval not required: Letter received 15/01/2015 from The Regional Ethics Committee (Southern Region of Denmark) deciding the study as a quality securing - or quality developing project, which falls out of the scope of the committees law given definition of a health scientific research project.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/04/2016 |
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URL:
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