Thoracic SurgeryNCT02461277
Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care
A study testing Fast-track protocol in people with Thoracic Surgery, run by Instituto do Coracao.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Fast-track protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled to undergo a thoracic surgical procedure
- sign the informed consent form
- independent ambulation
- ability to understand and follow instructions
Who cannot join
- contraindications for epidural catheter placement
- refusal to do physical exercises on postoperative
About this study
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.
Read the 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
- Being tested
- Fast-track protocol
- Keywords
- postoperative care, exercise test, early ambulation, Fast-track
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track protocolOther
Also called Early rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fast-track protocol |
| Conventional care | No intervention | Usual care routine postoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity of exercise ( six-minute walk test)
Change from baseline in distance walking on hospital discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes (3)
Time to first postoperative ambulation
Time from end of surgical procedure until first postoperative ambulation
Measured: up 2 hour after surgery
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).
Measured: expected average of 6 days
Surgical complications
Pneumonia, atelectasis, pneumothorax and air leak in the chest drainage
Measured: up 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sâmia Geórgia Dantas Linhares, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461277
- Sponsor's protocol ID
- Heart Institute InCor
- Status last verified
- May 2015
- First submitted
- 1 Jun 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care
- ClinicalTrials.gov ID
- NCT02461277
- Acronym / sponsor ID
- Heart Institute InCor
- Conditions
- Thoracic Surgery
- Keywords
- postoperative care, exercise test, early ambulation, Fast-track
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track protocol | Active comparator | Other: Fast-track protocolBefore 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. |
| Conventional care | No intervention | –Usual care routine postoperative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who are scheduled to undergo a thoracic surgical procedure
- sign the informed consent form
- independent ambulation
- ability to understand and follow instructions
Key exclusion criteria (2 listed)
- contraindications for epidural catheter placement
- refusal to do physical exercises on postoperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-track protocolAlso: Early rehabilitationPreoperatory 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 | Fast-track protocol |
Primary outcome
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
3 secondary outcomes
Time to first postoperative ambulation
Time frame: up 2 hour after surgery
The length of hospital stay
Time frame: expected average of 6 days
Surgical complications
Time frame: up 6 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-track protocol in people with Thoracic Surgery, run by Instituto do Coracao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.