Inadequate or Impaired Respiratory FunctionNCT02682771
Positive Airway Pressure Versus Breathing Exercises With Load Inspiratory in Patients Undergoing Bariatric Surgery
A study testing Bilevel positive airway pressure, PowerBreathe and Conventional Respiratory Physiotherapy (CRP) in people with Inadequate or Impaired Respiratory Function, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inadequate or Impaired Respiratory Function
- What is being tested?
- Bilevel positive airway pressure, PowerBreathe and Conventional Respiratory Physiotherapy (CRP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Dec 2015
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Submitted to Roux-en-Y type gastric bypass by laparotomy
- Normal preoperative pulmonary function and chest x-ray
Who cannot join
- Hemodynamic instability
- Hospital Stay longer than three days
- Presence of postoperative complications
- Smoking
- Respiratory chronic diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metodista de Piracicaba
Piracicaba, São Paulo, 13400911
About this study
Official title: Effects of Positive Airway Pressure and Incentive With Load Inspiratory on Lung Function and Respiratory Muscle in Post-bariatric Surgery - a Randomized and Blind Clinical Trial
Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.
Read the detailed description
This is a clinical trial, randomized, blinded, in which 60 volunteers, after evaluation preoperatively, consisting of: cirtometry to measure thoracoabdominal mobility, spirometry for measures of lung function, nasal inspiratory pressure to inspiratory muscle strength and endurance incremental test for evaluation of respiratory muscle strength, were randomized and allocated into three groups, with 20 volunteers each. The interventions were performed in the immediate postoperative period and the first day after surgery. The first group, called the control group received care by Conventional Respiratory Physiotherapy (CRP), consisting of breathing exercises, incentive spirometer and ambulation. The second group, called Positive Pressure Group received two-level positive airway pressure for one hour, addition of CRP. The third group, called Load Inspiratory Group held exercises with inspiratory pressure with linear load, linked also to the CRP. Treatments were applied twice in the immediate postoperative period and shortly after returning to the ward and after 4 hours of the initial treatment and three times a day on the first day after surgery. On discharge, the second day after surgery, the volunteers performed chest x-ray and underwent the same evaluations performed preoperatively.
- Being tested
- Bilevel positive airway pressure, PowerBreathe, Conventional Respiratory Physiotherapy (CRP)
- Keywords
- gastroplasty, breathing exercices, positive pressure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel positive airway pressureDevice
The use of positive airway pressure airway seeking in the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume
PowerBreatheDevice
Exercises with inspiratory load has the aim to trainning inspiratory muscle in strength and endurance, thus, could help to prevent postoperative complications.
Conventional Respiratory Physiotherapy (CRP)Procedure or surgery
CRP consisted of diaphragmatic respiratory exercises, deep inhalation exercises, inhalations fragmented two to three times and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs. One series of 10 repetitions was carried out for each exercise. Walking sessions and preventive exercises for deep vein thrombosis were carried out
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day. Receives: Procedure: Conventional Respiratory Physiotherapy (CRP) |
| Bilevel positive airway pressure | Experimental | Individuals were treated with positive pressure, in the BIPAP mode (bilevel positive airway pressure, with inspiratory pressure:12 cmH20 and expiratory pressure: 8 cmH20) twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each Receives: Device: Bilevel positive airway pressure; Procedure: Conventional Respiratory Physiotherapy (CRP) |
| Load inspiratory breathing exercises | Experimental | Individuals were treat with PowerBreathe, a device for inspiratory muscle, with 40% maximal inspiratory pressure, measured at preoperative, twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each. Receives: Device: PowerBreathe; Procedure: Conventional Respiratory Physiotherapy (CRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lumg volumes and flows: slow vital capacity, forced vital capacity and maximum voluntary ventilation. The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attemps. The values extracted from each maneuver were selected according to Pereira (2002) and the predicted values calculated using the equation proposed by Pereira et al (1992( for Brazilians.
Measured: up to 2 days after surgery
Secondary outcomes (3)
Thoracoabdominal mobility
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurement were made at levels axillary, xiphoid and abdominal during rest and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Measured: up to 2 days after surgery
Evaluation of inspiratory muscle endurance
The endurance test was performed using the PowerBreathe K3. An incremental test was performed, initiating at 30% of maximal inspiratory pressure for 30 respiratory cycles and then, added 10 cmH20 for each respiratory cycle. The test was finished when the individual was unabled to promote inspiratory effort.
Measured: up to 2 days after surgery
Evaluation of muscle strength inspiratory
The Sniff is an alternative non-invasive technique for the assessment of inspiratory muscle strength by sniff nasal inspiratory pressure (PNSN). The measurement is performed using a peak pressure generated by nasal nostril during a maximal sniff from functional residual capacity
Measured: up to 2 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 posted15 Feb 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequate or Impaired Respiratory FunctionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Maria Pazzianotto Forti, Universidade Metodista de Piracicaba
- Investigators
- Eli Maria Pazzianotto-Forti, PhD, Principal investigator, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682771
- Sponsor's protocol ID
- UMetodistaPiracicaba
- Status last verified
- Feb 2016
- First submitted
- 22 Jan 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive Airway Pressure and Incentive With Load Inspiratory on Lung Function and Respiratory Muscle in Post-bariatric Surgery - a Randomized and Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02682771
- Acronym / sponsor ID
- UMetodistaPiracicaba
- Keywords
- gastroplasty, breathing exercices, positive pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Feb 2016 (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.
Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.
Detailed description
This is a clinical trial, randomized, blinded, in which 60 volunteers, after evaluation preoperatively, consisting of: cirtometry to measure thoracoabdominal mobility, spirometry for measures of lung function, nasal inspiratory pressure to inspiratory muscle strength and endurance incremental test for evaluation of respiratory muscle strength, were randomized and allocated into three groups, with 20 volunteers each. The interventions were performed in the immediate postoperative period and the first day after surgery. The first group, called the control group received care by Conventional Respiratory Physiotherapy (CRP), consisting of breathing exercises, incentive spirometer and ambulation. The second group, called Positive Pressure Group received two-level positive airway pressure for one hour, addition of CRP. The third group, called Load Inspiratory Group held exercises with inspiratory pressure with linear load, linked also to the CRP. Treatments were applied twice in the immediate postoperative period and shortly after returning to the ward and after 4 hours of the initial treatment and three times a day on the first day after surgery. On discharge, the second day after surgery, the volunteers performed chest x-ray and underwent the same evaluations performed preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Conventional Respiratory Physiotherapy (CRP)Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day. |
| Bilevel positive airway pressure | Experimental | Device: Bilevel positive airway pressure, Procedure: Conventional Respiratory Physiotherapy (CRP)Individuals were treated with positive pressure, in the BIPAP mode (bilevel positive airway pressure, with inspiratory pressure:12 cmH20 and expiratory pressure: 8 cmH20) twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each |
| Load inspiratory breathing exercises | Experimental | Device: PowerBreathe, Procedure: Conventional Respiratory Physiotherapy (CRP)Individuals were treat with PowerBreathe, a device for inspiratory muscle, with 40% maximal inspiratory pressure, measured at preoperative, twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Submitted to Roux-en-Y type gastric bypass by laparotomy
- Normal preoperative pulmonary function and chest x-ray
Key exclusion criteria (5 listed)
- Hemodynamic instability
- Hospital Stay longer than three days
- Presence of postoperative complications
- Smoking
- Respiratory chronic diseases
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 |
|---|---|---|
| Bilevel positive airway pressureThe use of positive airway pressure airway seeking in the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume | Device | Bilevel positive airway pressure |
| PowerBreatheExercises with inspiratory load has the aim to trainning inspiratory muscle in strength and endurance, thus, could help to prevent postoperative complications. | Device | Load inspiratory breathing exercises |
| Conventional Respiratory Physiotherapy (CRP)CRP consisted of diaphragmatic respiratory exercises, deep inhalation exercises, inhalations fragmented two to three times and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs. One series of 10 repetitions was carried out for each exercise. Walking sessions and preventive exercises for deep vein thrombosis were carried out | Procedure or surgery | Bilevel positive airway pressure, Control, Load inspiratory breathing exercises |
Primary outcome
Pulmonary function
Time frame: up to 2 days after surgery
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lumg volumes and flows: slow vital capacity, forced vital capacity and maximum voluntary ventilation. The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attemps. The values extracted from each maneuver were selected according to Pereira (2002) and the predicted values calculated using the equation proposed by Pereira et al (1992( for Brazilians.
3 secondary outcomes
Thoracoabdominal mobility
Time frame: up to 2 days after surgery
Evaluation of inspiratory muscle endurance
Time frame: up to 2 days after surgery
Evaluation of muscle strength inspiratory
Time frame: up to 2 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 17 Feb 2016.
- Individual participant dataSharing planned: No
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.
Eli Maria Pazzianotto-Forti, PhD principal investigator
Universidade Metodista de Piracicaba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel positive airway pressure, PowerBreathe and Conventional Respiratory Physiotherapy (CRP) in people with Inadequate or Impaired Respiratory Function, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
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 2 inclusion and 5 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pulmonary function (time frame: up to 2 days after surgery). 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 17 Feb 2016.