Bariatric SurgeryNCT02577744
Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery
A study testing Noninvasive Ventilation and Expiratory Positive Air Pressure in people with Bariatric Surgery and Obesity, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Bariatric Surgery, Obesity, Physical Therapy Modalities
- What is being tested?
- Noninvasive Ventilation and Expiratory Positive Air Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Dec 2018
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing bariatric surgery, of both sexes and aged between 20 and 50 years.
Who cannot join
- severe lung disease;
- patients with congestive heart failure (NYHA Class III or IV);
- coronary artery disease;
- presented hemodynamic instability (MAP <60 mmHg) or arrhythmias during the performance of techniques, plus any contraindications to perform the BS techniques, EPAP and NIV to consider: Trauma / facial injury that prevents the attachment of the mask, extreme anxiety, hypotension and lack of patient cooperation.
Trial locations and contacts
1 site in 1 country.
Armele FD Andrade, Doctor contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas
Recife, Pernambuco
Célia Castro, Teaching and Research Manager, +5581 2126 3984, depex.hc@gmail.com
About this study
Official title: Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function, Regional Lung Ventilation and Respiratory Mechanics on Patients Submitted Bariatric Surgery Evaluated by Spirometry and Electric Impedance Tomography: A Clinical Trial Controlled Randomized
Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced long-term weight. It is well documented in the literature regarding the association of abdominal surgery and the incidence of respiratory complications and its main characteristics are: atelectasis, pneumonia, respiratory dysfunction and pleural effusion. All these respiratory complications can be minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary atelectasis is considered the main cause of complications. An arsenal of resources to physical therapy lung expansion, among these, the application of positive pressure through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and aims to prevent and / or improve the complications resulting from postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory system, without suffering the same interference conditions of patients, such as pain and bed rest. TIE consists of a method that measures passively regional lung ventilation. The aim of this study is to compare the effects of the application of EPAP and NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled trial where patients will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd postoperative day where they will be evaluated before, during and after the application of the techniques.
- Conditions
- Bariatric Surgery, Obesity, Physical Therapy Modalities
- Being tested
- Noninvasive Ventilation, Expiratory Positive Air Pressure
- Keywords
- Electrical Impedance Tomography
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive VentilationOther
Also called NIV
Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.
Expiratory Positive Air PressureOther
Also called EPAP
EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Ventilation | Active comparator | Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight. Receives: Other: Noninvasive Ventilation; Other: Expiratory Positive Air Pressure |
| Expiratory Positive Air Pressure | Active comparator | EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O. Receives: Other: Noninvasive Ventilation; Other: Expiratory Positive Air Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Pulmonary Ventilation
Assessment of regional ventilation through the variables of electrical impedance tomography , Delta Z (impedance variation) in the anterior and posterior region, and right and left lung.
Measured: six months
Secondary outcomes (5)
Effects of bariatric surgery on respiratory muscle strength
Assessment of maximum inspiratory pressure by manometer before and after bariatric surgery .
Measured: Six months
Patient perception of evaluation and assessing the quality of postoperative recovery
Evaluation by applying the Global Quality of recovery -40 questionnaire (QoR -40) at 24 and 48 hours after the surgical procedure.
Measured: Six months
Effects of bariatric surgery on lung function
Evaluation by spirometry, considering the variables, CV, FEV1, FVC, PEF, FEV1/FVC, FEF 25-75 %.
Measured: Six months
Adverse effects of technical and EPAP NIV
Through evaluation of open questions about the occurrence of adverse effects during the technique, such as headache, nausea, dizziness, discomfort, nausea and vomiting.
Measured: Six months
Therapeutic effect time of the EPAP and NIV
Quantify the therapeutic effect of time of the technical EPAP and NIV by analyzing the variables of the impedance electrical tomography , Average electrical impedance at the end of expiration (MIEFE) and monitoring this baseline during the post technique period at times 5 and 30 minutes post intervention.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sóstynis José de Albuquerque Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577744
- Sponsor's protocol ID
- 38032414.3.0000.5208
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function, Regional Lung Ventilation and Respiratory Mechanics on Patients Submitted Bariatric Surgery Evaluated by Spirometry and Electric Impedance Tomography: A Clinical Trial Controlled Randomized
- ClinicalTrials.gov ID
- NCT02577744
- Acronym / sponsor ID
- 38032414.3.0000.5208
- Conditions
- Bariatric Surgery, Obesity, Physical Therapy Modalities
- Keywords
- Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Oct 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.
Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced long-term weight. It is well documented in the literature regarding the association of abdominal surgery and the incidence of respiratory complications and its main characteristics are: atelectasis, pneumonia, respiratory dysfunction and pleural effusion. All these respiratory complications can be minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary atelectasis is considered the main cause of complications. An arsenal of resources to physical therapy lung expansion, among these, the application of positive pressure through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and aims to prevent and / or improve the complications resulting from postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory system, without suffering the same interference conditions of patients, such as pain and bed rest. TIE consists of a method that measures passively regional lung ventilation. The aim of this study is to compare the effects of the application of EPAP and NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled trial where patients will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd postoperative day where they will be evaluated before, during and after the application of the techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Ventilation | Active comparator | Other: Noninvasive Ventilation, Other: Expiratory Positive Air PressureNoninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight. |
| Expiratory Positive Air Pressure | Active comparator | Other: Noninvasive Ventilation, Other: Expiratory Positive Air PressureEPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing bariatric surgery, of both sexes and aged between 20 and 50 years.
Key exclusion criteria (4 listed)
- severe lung disease;
- patients with congestive heart failure (NYHA Class III or IV);
- coronary artery disease;
- presented hemodynamic instability (MAP <60 mmHg) or arrhythmias during the performance of techniques, plus any contraindications to perform the BS techniques, EPAP and NIV to consider: Trauma / facial injury that prevents the attachment of the mask, extreme anxiety, hypotension and lack of patient cooperation.
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 |
|---|---|---|
| Noninvasive VentilationAlso: NIVNoninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight. | Other | Expiratory Positive Air Pressure, Noninvasive Ventilation |
| Expiratory Positive Air PressureAlso: EPAPEPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O. | Other | Expiratory Positive Air Pressure, Noninvasive Ventilation |
Primary outcome
Regional Pulmonary Ventilation
Time frame: six months
Assessment of regional ventilation through the variables of electrical impedance tomography , Delta Z (impedance variation) in the anterior and posterior region, and right and left lung.
5 secondary outcomes
Effects of bariatric surgery on respiratory muscle strength
Time frame: Six months
Patient perception of evaluation and assessing the quality of postoperative recovery
Time frame: Six months
Effects of bariatric surgery on lung function
Time frame: Six months
Adverse effects of technical and EPAP NIV
Time frame: Six months
Therapeutic effect time of the EPAP and NIV
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
Armele FD Andrade, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Ventilation and Expiratory Positive Air Pressure in people with Bariatric Surgery and Obesity, run by Universidade Federal de Pernambuco 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 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sóstynis JA Silva, Mastering (+558199750784, sostynis@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Pulmonary Ventilation (time frame: six months). 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 Jan 2018.