Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 yrs or older

scheduled to undergo elective VATS segmental or lobar resection of the lung

Disqualifiers

Pulmonary function tests demonstrating forced expiratory volume in 1 second Forced Expiratory Volume (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide Lung Diffusion Test (DLCO) <50% predicted

Patient receives an intraoperative pleurodesis

Conversion to open thoracotomy or mini thoracotomy intraoperatively.

Underlying cognitive disorder resulting in inability to complete activities of daily living.

Trial design

Design model

Crossover

Treatments tested in this trial

  • early chest tube removal

    Procedure/Surgery

    Chest tube removal

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Early Chest Tube RemovalExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of successful same day chest tube removal

These patients have chest tube removed if they meet study criteria

Time frame
30 days post-op
2

EuroQol 5 Dimension 5 Level (EQ5D5L) score

Difference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.

Time frame
30 days post-op
3

Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1)

Mean Morphine Equivalents used on post operative day 1

Time frame
24 hours
4

Pleural reintervention

Rate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)

Time frame
30 days post-op

Secondary outcomes

1

Complications

The rates of grade 1 to 5 complications as per the Thoracic Surgery Quality Improvement Canada (TSQIC) will be recorded for up to 30 days after surgery in the divisional thoracic REDCap database.

Time frame
30 days post-op
2

Chest Tube duration

Duration the patient had chest tubes in situ will be measured by collecting the date and time of arrival to Post anesthesia Care Unit (PACU) and the date and time the chest tube was removed.

Time frame
30 days post-op
3

Unplanned return

Unplanned returns to clinic or emergency room within the first 30 days after surgery

Time frame
30 days post-op
4

Length Of Stay

Duration of hospital length of stay

Time frame
30 days post-op

Other outcomes

Sponsors and contacts

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