Pulmonary AtelectasisNCT01872663
Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery
A study testing Continuous positive airway pressure, Incentive spirometry and Breath Stacking in people with Pulmonary Atelectasis and Respiratory Tract Diseases, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty. It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
- What is being tested?
- Continuous positive airway pressure, Incentive spirometry and Breath Stacking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 40 and 55 Kg/m²
- Aged between 25 and 55 years
- Submitted to Roux-en-Y type gastric by-pass by laparotomy
- Normal preoperative pulmonary function test
Who cannot join
- Hemodynamic instability
- Hospital stay longer than three days
- Presence of postoperative complications
- Smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metodista de Piracicaba (UNIMEP)
Piracicaba, São Paulo, 13400911
About this study
Official title: Influence of Different Physical Therapy Resources Application After Abdominal Surgery
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty.
It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.
Read the detailed description
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative.
Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included.
The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery:
G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration).
The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.
- Conditions
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
- Being tested
- Continuous positive airway pressure, Incentive spirometry, Breath Stacking, Expiratory Positive Airway Pressure, Intermittent positive pressure breathing
- Keywords
- Morbid obesity, Bariatric surgery, Pulmonary atelectasis, Spirometry, Continuos Positive Airway Pressure, Physical therapy speciality
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureProcedure or surgery
The use of positive pressure airway seeking 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.
Incentive spirometryProcedure or surgery
The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.
Breath StackingProcedure or surgery
The method allowed to obtain a maximum lung expansion with minimal patient compliance.
Expiratory Positive Airway PressureProcedure or surgery
The use of positive pressure airway seeking 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.
Intermittent positive pressure breathingProcedure or surgery
The use of positive pressure airway seeking 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.
Bi-level positive airway pressureProcedure or surgery
The use of positive pressure airway seeking 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.
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometry (Voldyne®) | Experimental | Individuals will be treated with incentive spirometry, Voldyne Model 5000® in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. Receives: Procedure: Incentive spirometry |
| Continuous positive airway pressure | Experimental | Individuals will be treated with flow generator(Whisperflow, Caradyne, Ireland)and valve PEEP type spring-loaded which remain 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them. Receives: Procedure: Continuous positive airway pressure; Procedure: Expiratory Positive Airway Pressure |
| Expiratory Positive Airway Pressure | Experimental | Subjects will be treated with oronasal mask affixed to the face, with the PEEP valve set at 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. Receives: Procedure: Continuous positive airway pressure; Procedure: Expiratory Positive Airway Pressure |
| Intermittent positive pressure breathing | Experimental | Subjects will be treated with application of Müller Resuscitator (Engesp®) through a nozzle, using a pressure endotracheal 20-30 cmH2O, refering to 2-3 kgf/cm², adjusted throttle valve oxygen, according to the patient's comfort and the micronebulizer coupled only saline as the diluent. The procedure will be performed in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. Receives: Procedure: Continuous positive airway pressure; Procedure: Intermittent positive pressure breathing |
| Bi-level positive airway pressure | Experimental | Individuals will be treated with positive pressure in the BiPAP mode (Bi-level positive airway pressure) in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them. Receives: Procedure: Continuous positive airway pressure; Procedure: Expiratory Positive Airway Pressure; Procedure: Bi-level positive airway pressure |
| Breath Stacking | Experimental | Subjects will be treated with a siliconized mask connected to a unidirectional valve and adapted to the patient's face, allowing only the inspiration and the expiratory limb remains occluded, while the volunteer is instructed to perform successives inspiratory efforts, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. Receives: Procedure: Breath Stacking |
| Control | No intervention | Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital. |
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 lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. 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: 2 days after surgery
Secondary outcomes (3)
Prevalence of atelectasis
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Measured: 2 days after surgery
Thoracoabdominal mobility
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements 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 the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Measured: 2 days after surgery
Peak cough flow
The peak flow measured during a cough maneuver will be measured by the equipment Peak Flow ®. For this, the volunteer will be instructed to place the mouthpiece between the lips of the equipment and play a cough with nostrils occluded nose clip. The maneuver should be repeated three times and the best preoperative measures will be compared to the best postoperative measurement.
Measured: 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 posted7 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary AtelectasisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Eli Maria Pazzianotto Forti, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872663
- Sponsor's protocol ID
- Patricia2013
- Other IDs
- UNIMEP2013
- Status last verified
- Dec 2013
- First submitted
- 4 Jun 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Brigatto P, Carbinatto JC, Costa CM, Montebelo MI, Rasera-Junior I, Pazzianotto-Forti EM. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial. Braz J Phys Ther. 2014 Nov-Dec;18(6):553-62. doi: 10.1590/bjpt-rbf.2014.0054. Epub 2015 Jan 9.
PubMed 25590448
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Physical Therapy Resources Application After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01872663
- Acronym / sponsor ID
- Patricia2013
- Conditions
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
- Keywords
- Morbid obesity, Bariatric surgery, Pulmonary atelectasis, Spirometry, Continuos Positive Airway Pressure, Physical therapy speciality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jun 2013 (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 will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty.
It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.
Detailed description
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative.
Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included.
The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery:
G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration).
The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometry (Voldyne®) | Experimental | Procedure: Incentive spirometryIndividuals will be treated with incentive spirometry, Voldyne Model 5000® in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. |
| Continuous positive airway pressure | Experimental | Procedure: Continuous positive airway pressure, Procedure: Expiratory Positive Airway PressureIndividuals will be treated with flow generator(Whisperflow, Caradyne, Ireland)and valve PEEP type spring-loaded which remain 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them. |
| Expiratory Positive Airway Pressure | Experimental | Procedure: Continuous positive airway pressure, Procedure: Expiratory Positive Airway PressureSubjects will be treated with oronasal mask affixed to the face, with the PEEP valve set at 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. |
| Intermittent positive pressure breathing | Experimental | Procedure: Continuous positive airway pressure, Procedure: Intermittent positive pressure breathingSubjects will be treated with application of Müller Resuscitator (Engesp®) through a nozzle, using a pressure endotracheal 20-30 cmH2O, refering to 2-3 kgf/cm², adjusted throttle valve oxygen, according to the patient's comfort and the micronebulizer coupled only saline as the diluent. The procedure will be performed in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. |
| Bi-level positive airway pressure | Experimental | Procedure: Continuous positive airway pressure, Procedure: Expiratory Positive Airway Pressure, Procedure: Bi-level positive airway pressureIndividuals will be treated with positive pressure in the BiPAP mode (Bi-level positive airway pressure) in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them. |
| Breath Stacking | Experimental | Procedure: Breath StackingSubjects will be treated with a siliconized mask connected to a unidirectional valve and adapted to the patient's face, allowing only the inspiration and the expiratory limb remains occluded, while the volunteer is instructed to perform successives inspiratory efforts, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them. |
| Control | No intervention | –Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI between 40 and 55 Kg/m²
- Aged between 25 and 55 years
- Submitted to Roux-en-Y type gastric by-pass by laparotomy
- Normal preoperative pulmonary function test
Key exclusion criteria (4 listed)
- Hemodynamic instability
- Hospital stay longer than three days
- Presence of postoperative complications
- Smoking
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 |
|---|---|---|
| Continuous positive airway pressureThe use of positive pressure airway seeking 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. | Procedure or surgery | Bi-level positive airway pressure, Continuous positive airway pressure, Expiratory Positive Airway Pressure, Intermittent positive pressure breathing |
| Incentive spirometryThe volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis. | Procedure or surgery | Incentive spirometry (Voldyne®) |
| Breath StackingThe method allowed to obtain a maximum lung expansion with minimal patient compliance. | Procedure or surgery | Breath Stacking |
| Expiratory Positive Airway PressureThe use of positive pressure airway seeking 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. | Procedure or surgery | Bi-level positive airway pressure, Continuous positive airway pressure, Expiratory Positive Airway Pressure |
| Intermittent positive pressure breathingThe use of positive pressure airway seeking 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. | Procedure or surgery | Intermittent positive pressure breathing |
| Bi-level positive airway pressureThe use of positive pressure airway seeking 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. | Procedure or surgery | Bi-level positive airway pressure |
Primary outcome
Pulmonary function
Time frame: 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 lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. 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
Prevalence of atelectasis
Time frame: 2 days after surgery
Thoracoabdominal mobility
Time frame: 2 days after surgery
Peak cough flow
Time frame: 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 3 Dec 2013.
- Derived from this study: PubMed 25590448Brigatto P, Carbinatto JC, Costa CM, Montebelo MI, Rasera-Junior I, Pazzianotto-Forti EM. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial. Braz J Phys Ther. 2014 Nov-Dec;18(6):553-62. doi: 10.1590/bjpt-rbf.2014.0054. Epub 2015 Jan 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure, Incentive spirometry and Breath Stacking in people with Pulmonary Atelectasis and Respiratory Tract Diseases, 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 4 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 3 Dec 2013. 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: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872663, which also lists 1 linked publication.
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 Dec 2013.