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

NCT ID: NCT02461277

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

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.

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.

Conditions

Thoracic Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fast-track protocol

Intervention Type: 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.

Conventional care

Usual care routine postoperative

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Early rehabilitation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sâmia Geórgia Dantas Linhares

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Heart Institute InCor

Identifier Type: -

Identifier Source: org_study_id