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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Other: Fast-track protocol

Detailed Description

Fast track programs represents a new approach to the management of patients undergoing surgery. It is perioperative care pathway designed to achieve early recovery and helps to minimize postoperative morbidity and mortality.

These multimodal approaches focuses on enhancing recovery and reducing of surgical stress by minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity.

However, information on the results of Fast-track protocols in functional capacity of exercise during hospital stay is sparse.

The six-minute walk test is use to measure of functional capacity of exercise in different populations and to detect changes after interventions. The distances traveled in two six-minute walk test (preoperative and postoperative) will be compared between the two groups (Fast-track and Conventional).

In this trial the investigators will consider Fast-track protocol to be feasible to enhance functional capacity of exercise after thoracic surgery.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fast-track protocol; 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; 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.; Other Names: Early rehabilitation
NO_INTERVENTION: Conventional care; Usual care routine postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of hospital stay	Time to achieve standardized hospital discharge criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self care and no evidence of complications or untreated medical problems).	expected average of 6 days
Time to first postoperative ambulation	Time from end of surgical procedure until first postoperative ambulation	up 2 hour after surgery
Surgical complications	Pneumonia, atelectasis, pneumothorax and air leak in the chest drainage	up 6 days after surgery

Collaborators and Investigators

• Sponsor: Instituto do Coracao

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (ESTIMATE): June 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: exercise test; postoperative care; Fast-track; early ambulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Heart Institute InCor