Suction on Post-Operative Chest Tubes (SPOCT)

April 26, 2018 updated by: Bo Laksáfoss Holbek, Rigshospitalet, Denmark

Suction on Post-Operative Chest Tubes After Video-Assisted Thoracoscopic Surgery Lobectomy for Presumed or Confirmed Primary Lung Cancer - At Which Level?

The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems.

Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Speaks and understands Danish.
  • Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.

Exclusion Criteria:

  • Cannot cooperate or unable to give consent.
  • Chronic drain carrier.
  • Planned open procedure.
  • Planned resection of additional wedge, additional lobe or thoracic wall.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Post-operative suction is set to -2 cmH2O.
Device: Suction is set to -2 cmH2O
Post-operative suction is set to -2 cmH2O (intervention).
Active Comparator: Group 2
Post-operative suction is set to -10 cmH2O (standard treatment).
Device: Suction is set to -10 cmH2O
Post-operative suction is set to -10 cmH2O (standard treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest tube duration through study completion, an average of 3 days.
Time Frame: Through study completion, an average of 3 days.
Time from intraoperative chest tube placement to it's removal.
Through study completion, an average of 3 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to removal criteria have been fulfilled up to 24 hours
Time Frame: Duration from the post-operative chest tube has been placed, until it's potential removal.
Chest tubes can be removed when the patient has been mobilized and the air leakage has not superceeded 20 mL/min in 12 hours and fluid production has not superceded 500 mL in 24 hours.
Duration from the post-operative chest tube has been placed, until it's potential removal.
Number of participants with prolonged air leak
Time Frame: Through study completion, an average of 7 days
Through study completion, an average of 7 days
Number of participants requiring treatment for prolonged air leak.
Time Frame: Through study completion, an average of 14 days
Through study completion, an average of 14 days
Number of participants requiring treatment for subcutaneous emphysema.
Time Frame: Through study completion, an average of 14 days
Through study completion, an average of 14 days
Number of participants with pneumonia or empyema.
Time Frame: Through study completion, an average of 21 days
Through study completion, an average of 21 days
Length of stay.
Time Frame: Through study completion, an average of 3 days
Through study completion, an average of 3 days
Number of participants with other respiratory problems.
Time Frame: Through study completion, an average of 30 days
Through study completion, an average of 30 days
Number of participants requiring readmission for thoracic surgical complications.
Time Frame: Through study completion, an average of 30 days
Through study completion, an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Medela AG

Investigators

  • Principal Investigator: Bo L. Holbek, MD, Rigshospitalet, Denmark
  • Study Director: Merete Christensen, MD, Rigshospitalet, Denmark
  • Study Chair: Jesper Ravn, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15008900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

Clinical Trials on Suction is set to -2 cmH2O

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe