Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care

NCT02461277 | Completed DMC

• 1 other identifier: Heart Institute InCor
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to compare the functional capacity of exercise by six-minute walk test before and after thoracic surgical procedure in subjects who have undergone the Fast-track protocol with those who were under conventional care. Researchers want to find out if Fast-track is a strategy to enhance functional capacity after thoracic surgery.

Conditions

Thoracic Surgery

Keywords

postoperative care; exercise test; early ambulation; Fast-track

Outcome Measures

Primary Outcomes (1)

• Functional capacity of exercise ( six-minute walk test)

  Change from baseline in distance walking on hospital discharge

  participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcomes (3)

• Time to first postoperative ambulation

  up 2 hour after surgery

• The length of hospital stay

  expected average of 6 days

• Surgical complications

  up 6 days after surgery

Study Arms (2)

Fast-track protocol

ACTIVE COMPARATOR

Before surgery, patients are informed about the surgical procedure, anesthesia and rehabilitation protocol. The surgery occurs in accordance with the principles of the Fast-track: minimal invasive surgery, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization.

Other: Fast-track protocol

Conventional care

NO INTERVENTION

Usual care routine postoperative

Interventions

Fast-track protocol OTHER

Preoperatory management, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization. At the postoperative recovery room, after extubation and fully awake, patients started physiotherapy exercises, as physical exercises of moving up upper and lower extremities accompanied by deep breathing exercises. After than, the patients standed up beside the bed and if there was no complications, patients performed ambulation. The physiotherapist aided the patients during all period.

Also known as: Early rehabilitation

Fast-track protocol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are scheduled to undergo a thoracic surgical procedure
• sign the informed consent form
• independent ambulation
• ability to understand and follow instructions

You may not qualify if:

• contraindications for epidural catheter placement
• refusal to do physical exercises on postoperative

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 3, 2015

Record last verified: 2015-05