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Rationale: Evidence regarding the timing of chest tube removal after cardiac surgery is sparse. The timing of chest tubes removal constitutes a balancing act between risk of retained blood syndrome, infection, patient discomfort and opioid-related side effects. Several studies have shown that chest tubes can safely be removed on the first postoperative day compared to later. A single retrospective study raised concern as chest tube removal on the day of surgery was associated with an increased requirement of drainage of pleural effusions. Primary Objective: To compare the impact of two standard chest tube removal protocols following open-heart surgery on the incidence of pleural and/or pericardial effusion requiring invasive drainage Secondary Objectives To evaluate the impact of chest tube removal on the day of surgery (DAY0) compared to the first postoperative day (DAY1) regarding: * Comsumption of analgetic drugs * Early postoperative pain * Incidence of infection * Early postoperative respiratory function Study design: Single-center, open, parallel-group, prospective, cluster-randomized controlled trial Alternate assignment of chest tube removal according to Day 0 versus Day 1 protocol based upon the month of surgery (even versus odd months). Study population: 1300 consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dep. of Cardiothoracic Surgery, Aarhus University Hospital
Aarhus, Denmark
Start Date
September 1, 2020
Primary Completion Date
October 31, 2021
Completion Date
October 31, 2021
Last Updated
August 8, 2023
515
ACTUAL participants
Cardiac surgery
PROCEDURE
Lead Sponsor
Aarhus University Hospital Skejby
NCT07457788
NCT06531928
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06707454