Condition category
Surgery
Date applied
13/06/2019
Date assigned
01/07/2019
Last edited
01/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Air leakage following thoracic surgery is common and leads to increased morbidity, costs and length of hospitalization. An air leak not caused by an alveolo-pleural fistulae (true air leak) is termed false air leak. Unrecognized false air leakage results in unnecessarily prolonged chest tube duration, costs and risks of complications. The correct interpretation of whether the air leakage is true or false is consequently paramount to correct decision making and timing of safe chest drain removal.

Unfortunately, both traditional water seal and electronic drainage systems cannot distinguish false air leakage from true air leakage. The aim of the present study was to test a new chest drainage unit, where a CO2-sensitive colour indicator is integrated into the chest drainage unit to distinguish true air leakage form false air leakage.

Who can participate?
All of the patients that are eligible for surgery are informed before surgery by a doctor in written form and oral. All patients signing an informed consent form are included in the pilot study.

What does the study involve?
During a period of three weeks, 14 consecutive adult male and woman are operated in Dep of Cardiothoracic surgery, OUH, Denmark with open surgery and VATS surgery with minor resections of the lung (subsegmental resections) and major resections of the lung (lobectomies and bilobectomies). All patients are operated in general anaesthesia with double lumen intubation.

After the pilot study using only the chest drainage unit with CO2 indicator for all patients, the trial will continue with measurement of intrathoracic pressure with a pressure indicator inserted in the thoracic cavity. Pressure measurement will be performed for patients with the new chest drainage, a standard chest drainage unit and a digital chest drainage unit.

What are the possible benefits and risks of participating?
There are no direct benefits for the persons taking part in the trial. The risks are the same as risks involved in having a chest tube in general (wound infection, pain).

Where is the study run from?
Odense University Hospital

When is the study starting and how long is it expected to run for?
April 2019 to May 2020

Who is funding the study?
The study is funded by the Odense University Hospital and the Southern Denmark University Research & Innovation Organisation. The 14 chest drainage units are delivered without payment from the manufacturer Sinapi Biomedicals.

Who is the main contact?
Consultant Jens Eckardt
jens.eckardt@rsyd.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jens Eckardt

ORCID ID

Contact details

JB Winsløw 4
Odense
5000
Denmark
+4524621770
jens.eckardt@rsyd.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Acadre 17/33766

Study information

Scientific title

A newly developed chest drainage unit with an integrated CO2 detector: an observational case-control study

Acronym

N/A

Study hypothesis

Postoperative observed air leakage does not always originate from parenchymal defects but may arise from defects in the chest drainage unit, connections or reverse airflow in water seals. The aim of the present study was to test a new invention in the clinic, where a CO2-sensitive colour indicator is integrated in the chest drainage unit.

Ethics approval

The ethics board for the region of southern Denmark decided that there was no need for approval from an ethics committee.

Study design

pilot feasibility, observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Lung surgery, either open surgery or vats (video-assisted thoracoscopic surgery)

Intervention

All persons included in the trial according to the inclusion criteria are operated according to the recommendations in the department. Surgery is performed in general anesthesia and after the resection of the lung tissue, a chest tube (silicone tube ) is inserted. In the trial involving intrathoracic pressure measurement, an additional tube (plastic tube) is inserted (thickness 2-4 millimeter). When there is no air leakage from the lung tissue both tubes are removed followed by a chest x-ray after 2-4 hours. The operated persons are discharged from the hospital according to the recommendations in the department. The trial does not involve any follow-up. All information is collected from patient records. The trial run from the day of surgery until the person has been discharged from the hospital.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. The complication rate is measured by collecting data from patient records.
2. Chest tube reinsertion rate is measured by collecting data from patient records.
3. The length of chest tube duration is measured by collecting data from patient records.
4. The length of stay is measured using by collecting data from patient records.

Secondary outcome measures

The number of patients with false air leakage versus true air leakage is measured by collecting data from patient records.

Overall trial start date

01/07/2018

Overall trial end date

01/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 to 90 years.
2. Open or vats procedures with non-small lung cancer or undiagnosed lesions.
3. Lobectomies, bilobectomies or diagnostic resections of lung tissue.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

Patients who cannot give informed consent.

Recruitment start date

01/04/2019

Recruitment end date

01/05/2019

Locations

Countries of recruitment

Denmark

Trial participating centre

Odense University Hospital, Dep. Cardiothoracic surgery
JB Winsløw 4
Odense
5000
Denmark

Sponsor information

Organisation

Odense University Hospital, Dep of Cardiothoracic surgery

Sponsor details

JB Winsløw vej 4
Odense C
5000
Denmark
+4566 11 33 33
ouh.kontakt@rsyd.dk

Sponsor type

Hospital/treatment centre

Website

www.ouh.dk

Funders

Funder type

University/education

Funder name

Odense University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Southern Denmark University Research & Innovation Organisation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an internationally recognized journal focused on Cardiothoracic Surgery.

IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/09/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/06/2019: Trial's existence confirmed by the Scientific Ethics Committees for the Region of Southern Denmark.