Pulmonary AtelectasisNCT01786681
Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery
A study testing Positive pressure 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 was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing gastroplasty. 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?
- Positive pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Dec 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 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 bypass by laparotomy
- Normal preoperative pulmonary function test
Who cannot join
- Hemodynamic instability
- Hospital stay longer than three days
- Presence of postoperative complications
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metodista de Piracicaba (UNIMEP)
Piracicaba, São Paulo
About this study
Official title: Use of Positive Pressure in Morbidly Obese Patients Undergoing Gastroplasty
The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing gastroplasty.
It is believed that the application of these devices before, during or after surgery can help to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.
Read the detailed description
The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing Roux-en-Y gastric bypass with regard to: lung volumes and capacities, the prevalence of atelectasis, duration of surgery and diaphragmatic mobility.
Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary function test were included, but those with hemodynamic instability, a hospital stay longer than three days or the presence of postoperative complications were excluded.
The volunteers were divided into four different groups:
Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before surgery; Gpos: individuals treated with positive airway pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.
Gcont: individuals treated with conventional physiotherapy (CP) according to the routine service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion, breathing exercises (deep breaths or fractional), the use of incentive spirometry (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted) and assisted ambulation. It should be noted that the physiotherapist was blinded to the individual's participation in the groups, and all patients received conventional physiotherapy, independent of the group in which they were included.
The respiratory evaluation (preoperative and second postoperative days) consisted of collecting the anthropometric data, a pulmonary function test and a chest radiography (inspired and expired).
- Conditions
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
- Being tested
- Positive pressure
- Keywords
- Morbid obesity, Bariatric Surgery, Pulmonary Atelectasis, Spirometry, Continuous Positive Airway Pressure, Physical Therapy Specialty
- 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.
Positive pressureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Positive pressure before surgery | Experimental | Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before bariatric surgery. Receives: Procedure: Positive pressure |
| Positive pressure during the surgery | Experimental | Individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure. Receives: Procedure: Positive pressure |
| Positive pressure after surgery | Experimental | Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour after bariatric surgery. Receives: Procedure: Positive pressure |
| Control | No intervention | Individuals 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
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
Diaphragmatic mobility
The chest X-ray was made using two radiographic exposures, with the patient in the standing position. The first was taken at the end of a maximal inspiration, seeking the largest inspired lung volume (Total Lung Capacity - TLC), and the second in profound exhalation without changing the position of the film or the patient, seeking the maximum emptying of the lungs (Residual Volume - RV). The diaphragmatic motion was analyzed by superimposing the two radiological films, and calculating the distance between the highest point of the diaphragm in expiration and the highest point of the dome on bilateral inspiration.
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 posted8 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 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
- NCT01786681
- Sponsor's protocol ID
- Leticia2011
- Status last verified
- Feb 2013
- First submitted
- 31 Jan 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Positive Pressure in Morbidly Obese Patients Undergoing Gastroplasty
- ClinicalTrials.gov ID
- NCT01786681
- Acronym / sponsor ID
- Leticia2011
- Conditions
- Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
- Keywords
- Morbid obesity, Bariatric Surgery, Pulmonary Atelectasis, Spirometry, Continuous Positive Airway Pressure, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Feb 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 was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing gastroplasty.
It is believed that the application of these devices before, during or after surgery can help to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.
Detailed description
The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing Roux-en-Y gastric bypass with regard to: lung volumes and capacities, the prevalence of atelectasis, duration of surgery and diaphragmatic mobility.
Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary function test were included, but those with hemodynamic instability, a hospital stay longer than three days or the presence of postoperative complications were excluded.
The volunteers were divided into four different groups:
Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before surgery; Gpos: individuals treated with positive airway pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.
Gcont: individuals treated with conventional physiotherapy (CP) according to the routine service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion, breathing exercises (deep breaths or fractional), the use of incentive spirometry (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted) and assisted ambulation. It should be noted that the physiotherapist was blinded to the individual's participation in the groups, and all patients received conventional physiotherapy, independent of the group in which they were included.
The respiratory evaluation (preoperative and second postoperative days) consisted of collecting the anthropometric data, a pulmonary function test and a chest radiography (inspired and expired).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive pressure before surgery | Experimental | Procedure: Positive pressureSubjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before bariatric surgery. |
| Positive pressure during the surgery | Experimental | Procedure: Positive pressureIndividuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure. |
| Positive pressure after surgery | Experimental | Procedure: Positive pressureSubjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour after bariatric surgery. |
| Control | No intervention | –Individuals 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 bypass by laparotomy
- Normal preoperative pulmonary function test
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Hospital stay longer than three days
- Presence of postoperative complications
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 |
|---|---|---|
| Positive pressure | Procedure or surgery | Positive pressure after surgery, Positive pressure before surgery, Positive pressure during the surgery |
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.
Prevalence of atelectasis
Time frame: 2 days after surgery
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Thoracoabdominal mobility
Time frame: 2 days after surgery
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.
Diaphragmatic mobility
Time frame: 2 days after surgery
The chest X-ray was made using two radiographic exposures, with the patient in the standing position. The first was taken at the end of a maximal inspiration, seeking the largest inspired lung volume (Total Lung Capacity - TLC), and the second in profound exhalation without changing the position of the film or the patient, seeking the maximum emptying of the lungs (Residual Volume - RV). The diaphragmatic motion was analyzed by superimposing the two radiological films, and calculating the distance between the highest point of the diaphragm in expiration and the highest point of the dome on bilateral inspiration.
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 8 Feb 2013.
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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 Positive pressure 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 3 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 8 Feb 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). The study lists 4 primary outcomes in all. 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 8 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.