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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461277
• Other study ID #: Heart Institute InCor
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: June 1, 2015
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2015
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to first postoperative ambulation	Time from end of surgical procedure until first postoperative ambulation	up 2 hour after surgery	No
Secondary	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	No
Secondary	Surgical complications	Pneumonia, atelectasis, pneumothorax and air leak in the chest drainage	up 6 days after surgery	No