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Completed

NCT Number: NCT02461277

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Early rehabilitation

Primary outcomes

  1. Functional capacity of exercise ( six-minute walk test)

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

    Change from baseline in distance walking on hospital discharge

Secondary outcomes

  1. Time to first postoperative ambulation

    Time frame: up 2 hour after surgery

    Time from end of surgical procedure until first postoperative ambulation

  2. The length of hospital stay

    Time frame: expected average of 6 days

    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).

  3. Surgical complications

    Time frame: up 6 days after surgery

    Pneumonia, atelectasis, pneumothorax and air leak in the chest drainage

Sponsors and collaborators

Lead sponsor

Instituto do Coracao

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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