Trials / Terminated
TerminatedNCT04487262
Timing for Removal of Chest Tubes in Adult Cardiac Surgery
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 515 (actual)
- Sponsor
- Aarhus University Hospital Skejby · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cardiac surgery | Elective open heart surgery |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-10-31
- Completion
- 2021-10-31
- First posted
- 2020-07-27
- Last updated
- 2023-08-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04487262. Inclusion in this directory is not an endorsement.