Trial Outcomes & Findings for Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study (NCT NCT02808897)

Results Overview

Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode ≥ 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

520 participants

Primary outcome timeframe

From post index surgery through hospital discharge, an average of 30 days

Results posted on

2024-03-06

Participant Flow

257 patients were randomized in the Active Tube Clearance (ATC) group for 263 in the standard drainage group prior to early dropouts. Respectively, 241 and 249 patients were followed for the duration of the trial. 100 random patients were included in the direct visual analysis: 57 and 43 in each respective group.

30 patients were excluded after randomization because of the identification of an exclusion criteria Atrial fibrillation history (n = 10) Transcatheter aortic valve replacement (n = 1) Deep hypothermic arrest (n = 1) Active endocarditis (n = 3) Inherited bleeding disorder (n = 1) Minimally invasive procedure (n = 14)

Participant milestones

Participant milestones
Measure	Standard Drainage The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Clearance Technology drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Overall Study STARTED	249	241
Overall Study COMPLETED	240	230
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Drainage The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Clearance Technology drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Overall Study Lost to Follow-up	9	11

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (FR) shall be used. Use of silastic 19F chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Clearance Technology drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 FR shall be used. Use of silastic 19F chest tubes were left at the discretion of the operating surgeon.	Total n=490 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 10.8 • n=249 Participants	66.8 years STANDARD_DEVIATION 8.3 • n=241 Participants	66.3 years STANDARD_DEVIATION 9.6 • n=490 Participants
Sex: Female, Male Female	53 Participants n=249 Participants	46 Participants n=241 Participants	99 Participants n=490 Participants
Sex: Female, Male Male	196 Participants n=249 Participants	195 Participants n=241 Participants	391 Participants n=490 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From post index surgery through hospital discharge, an average of 30 days

Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode ≥ 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge.

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Participants With Postoperative Atrial Fibrillation	39 Participants	33 Participants

SECONDARY outcome

Timeframe: Within 30 days post index surgery

Any of the following: * Re-exploration for bleeding or cardiac tamponade * Pericardial drainage procedure (pericardiocentesis or pericardial window) * Pleural drainage procedure (thoracentesis, new chest tube, thoracoscopy or lateral thoracotomy)

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications)	27 Participants	15 Participants

SECONDARY outcome

Timeframe: within 30-day post index surgery

Rate of re-exploration for bleeding or tamponade within 30-day post index surgery

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Participants Requiring Re-exploration for Bleeding or Tamponade	14 Participants	4 Participants

SECONDARY outcome

Timeframe: At chest tube removal

Population: 100 random patients were included in this analysis where the chest tubes were visually inspected upon removal by a blinded investigator. They were selected by convenience, when the investigator was available.

Visual observation of mediastinal chest tube lumen upon removal to determine whether it is: * patent * partially occluded * totally occluded

Outcome measures

Outcome measures
Measure	Standard Drainage n=43 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=57 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Participants Presenting With a Chest Tube Occlusion Patent	26 Participants	42 Participants
Number of Participants Presenting With a Chest Tube Occlusion Partially obstructed	9 Participants	14 Participants
Number of Participants Presenting With a Chest Tube Occlusion Totally obstructed	8 Participants	1 Participants

SECONDARY outcome

Timeframe: within 30-day post index surgery

Rate of invasive pericardial drainage procedure within 30-day post index surgery

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Patients Requiring Pericardial Drainage Procedure	5 Participants	2 Participants

SECONDARY outcome

Timeframe: within 30-day post index surgery

Rate of invasive pleural drainage procedure within 30-day post index surgery

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Patients Requiring Pleural Drainage Procedure	8 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days post index surgery

Frequency of readmission for any indication

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Number of Patients Being Readmitted	24 Participants	27 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At chest tube removal

Total chest tube output (milliliter)

Outcome measures

Outcome measures
Measure	Standard Drainage n=249 Participants The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.	Active Tube Clearance Drainage n=241 Participants The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.
Total Chest Tube Output	640 milliliters Interval 430.0 to 815.0	580 milliliters Interval 440.0 to 900.0

Adverse Events

Standard Drainage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Active Tube Clearance Drainage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philippe Demers

Montreal Heart Institute

Phone: 5143763330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place