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Pulmonary Volumes After Cardiac SurgeryNCT01074957

Effects of Physical Therapy on Cardiac Surgery

A study testing Incentive Spirometry, Breath-Stacking Technique and Exercise in people with Pulmonary Volumes After Cardiac Surgery, run by Centro Universitário Augusto Motta.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Volumes After Cardiac Surgery
What is being tested?
Incentive Spirometry, Breath-Stacking Technique and Exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Nov 2007to Nov 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients were not included if any of the following criteria was present:
  • Informed consent could not be obtained
  • Could not perform the preoperative tests
  • Cognitive impairments to perform the IS
  • Intolerance to the use of BS mask

Who cannot join

  • Hemodynamic complications (intraoperative myocardial infarction
  • Major blood loss
  • Marked hypotension
  • Reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit

About this study

Official title: Effects of Physical Therapy on Pulmonary Volumes

Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period.

Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E) was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed progressive mobilization. Forced spirometry was carried out in the pre-operative period and from the first to the fifth postoperative day. Statistical analysis used student t-test and ANOVA, and the differences were considered significant when p<0.05.

Read the detailed description

This was a prospective, controlled and randomized clinical trial, conducted with patients undergoing cardiac surgery at Hospital de Força Aérea do Galeão (HFAG - Rio de Janeiro, RJ, Brazil). According to Helsinki declaration, the protocol was approved by UNISUAM Ethics Committee (process: 15/2007) and written informed consent was obtained from all participants. All patients at the HFAG, who were scheduled for cardiac surgery between November 2007 and February 2009 were eligible to participate in this study.

Patients were not included if any of the following criteria was present: informed consent could not be obtained, they could not perform the preoperative tests, cognitive impairments to perform the IS, intolerance to the use of BS mask. Exclusion criteria included: hemodynamic complications (intraoperative myocardial infarction, major blood loss, marked hypotension, reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit. In all patients the surgical procedure was through a median sternotomy, and the postoperative routine was the same, including optimal treatment for pain control. A verbal pain score was obtained using a visual analog scale and all patients initiated the physiotherapeutic treatment at the first postoperative day, following extubation. Demographic data, clinical history and preoperative risk factors were recorded.

In the preoperative period all patients were instructed about the importance of early mobilization and excessive bronchial secretion removal. Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). Then, they were randomly allocated into three groups. Exercise group (E) performed only the procedures described above. Incentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC). Breath-Stacking group (BS) performed inspiratory efforts using a facial mask adapted to an unidirectional valve. Since the mask was set to allow only inspiration (the expiratory branch was occluded), the patient carried through successive inspiratory efforts for a period of 20 seconds. Then, the expiratory branch was released allowing exhalation. These three treatments were applied for five days, with three series of five maneuvers twice a day. Patients management was similar among groups in terms of assessment, mobilization protocol and cough orientation.

For safety purposes, vital signs and oxygen saturation (SpO2) were monitored throughout the interventions. SpO2 was measured continuously for seven minutes using a portable pulse oximeter (Model 2500A, Nonin Medical INC; Plymouth, USA) with patient breathing room air. After seven minutes the most consistent value for 30 seconds was recorded and previous oxygen therapy was reinitiated. If during the assessment, patient's SpO2 dropped to below 85%, oxygen was recommenced and it was registered.

All procedures were performed under the supervision of an experienced physical therapist. Forced spirometry was carried out in the preoperative period and from the first to the fifth postoperative day, using a Pony Fx® spirometer (Cosmed; Rome, Italy). A Wright® ventilometer (British Oxygen Company; London, England) was properly attached to Voldyne and to Breath-Stacking mask, allowing to measure the Inspiratory Capacity (IC) during the procedures.

Postoperative risk was evaluated by means of Torrington Scale, using clinical and functional data.

Statistical Analysis Statistical analysis was done using Sigma Stat 3.1 (Jandel Scientific, San Rafael, CA, USA). Data are presented as average and standard error of the mean. They presented normal distributions (Kolmogorov-Smirnov test with Lilliefors' correction) and homogeneous variances (Levene median test). Comparisons of FVC between IS, BS and E were done with ANOVA, followed by Tukey test whenever multiple comparisons were required. Student's t-test was used to compare IC between IS and BS. The significance level was always set at 5%.

Being tested
Incentive Spirometry, Breath-Stacking Technique, Exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incentive SpirometryDevice

    Also called Voldyne

    Incentive Spirometry (IS) has been used extensively in postoperative period and consists of spontaneous deep breaths through a device which provides a visual feedback to maintain a maximum insuflation

  • Breath-Stacking TechniqueDevice

    Also called One-way inspiratory valve

    An one-way valve device to promote the summation of successive inspiratory volumes while expiration was avoided

  • ExerciseOther

    Also called Early mobilization

    Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).

Study groups in NCT01074957
Study groupRoleWhat they receive
Incentive SpirometryActive comparatorIncentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC).
Receives: Device: Incentive Spirometry
Exercise groupActive comparatorPatients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).
Receives: Other: Exercise
Breath-StackingActive comparatorBreath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve
Receives: Device: Breath-Stacking Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory volume

    Measured: First five postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2010 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2009
  4. Study completionNov 2009

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074957
Sponsor's protocol ID
UNISUAM
Other IDs
Mestrado UNISUAM
Status last verified
Feb 2010
First submitted
22 Feb 2010
Last updated
24 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Incentive Spirometry, Breath-Stacking Technique and Exercise in people with Pulmonary Volumes After Cardiac Surgery, run by Centro Universitário Augusto Motta.

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 5 inclusion and 4 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 24 Feb 2010. 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?

Respiratory volume (time frame: First five postoperative 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 24 Feb 2010.

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