Study of Postoperative Chest Tube Management

NCT02282462 | Completed Phase 4

• 1 other identifier: 1411014891
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection

Conditions

Lung Resection

Keywords

Chest tube

Outcome Measures

Primary Outcomes (1)

• Duration of air leak

  Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes \>80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction)

  up to 7 days

Secondary Outcomes (1)

• Time till chest tube removal

  up to 7 days

Other Outcomes (2)

• Duration of hospital stay

  up to 7 days

• Amount of fluid drained

  up to 7 days

Study Arms (4)

Reg pressure, Active suction (Dig)

EXPERIMENTAL

Regulated pleural pressure with active suction

Other: Reg Pressure; Other: Active Suction (Dig)

Reg pressure, Passive drainage (Dig)

EXPERIMENTAL

Regulated pleural pressure with passive drainage

Other: Reg Pressure; Other: Passive Drainage (Dig)

Unreg pressure, Active suction (Trad)

EXPERIMENTAL

Unregulated pleural pressure with active suction

Other: Unreg Pressure; Other: Active Suction (Trad)

Unreg pressure, Passive drainage (Trad)

EXPERIMENTAL

Unregulated pleural pressure with passive drainage

Other: Unreg Pressure; Other: Passive Drainage (Trad)

Interventions

Reg Pressure OTHER

Regulated Suction using the Thopaz+ digital chest drainage device

Reg pressure, Active suction (Dig); Reg pressure, Passive drainage (Dig)

Unreg Pressure OTHER

Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)

Unreg pressure, Active suction (Trad); Unreg pressure, Passive drainage (Trad)

Active Suction (Dig) OTHER

Thopaz+ digital chest drainage device set at -20cmH2O at the patient

Reg pressure, Active suction (Dig)

Active Suction (Trad) OTHER

Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.

Unreg pressure, Active suction (Trad)

Passive Drainage (Dig) OTHER

Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")

Reg pressure, Passive drainage (Dig)

Passive Drainage (Trad) OTHER

Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')

Unreg pressure, Passive drainage (Trad)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to read, understand, and provide written consent
• Age 18-90
• Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable

You may not qualify if:

• Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
• Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
• Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
• Patients undergoing pneumonectomy or completion pneumonectomy

Sponsors & Collaborators

• Yale University: lead
• Medela AG: collaborator

Study Sites (5)

Yale University

New Haven, Connecticut, 06519, United States

Location

WellStar Health System - Kennestone

Marietta, Georgia, 30066, United States

Location

Beth Israel Deaconess/ Harvard

Boston, Massachusetts, 02215, United States

Location

Valley Health System

Paramus, New Jersey, 07653, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Study Officials

• Frank Detterbeck, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 4, 2014
• Study Start: December 1, 2014
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (5)