Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02577744
• Other study ID #: 38032414.3.0000.5208
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: December 29, 2017
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Universidade Federal de Pernambuco
• Contact: Sóstynis JA Silva, Mastering
• Phone: +558199750784
• Email: sostynis[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients undergoing bariatric surgery, of both sexes and aged between 20 and 50 years.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Physical Therapy Modalities

Intervention

Other:
• Noninvasive Ventilation
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 Pressure
EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months
Secondary	Effects of bariatric surgery on respiratory muscle strength	Assessment of maximum inspiratory pressure by manometer before and after bariatric surgery .	Six months
Secondary	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.	Six months
Secondary	Effects of bariatric surgery on lung function	Evaluation by spirometry, considering the variables, CV, FEV1, FVC, PEF, FEV1/FVC, FEF 25-75 %.	Six months
Secondary	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.	Six months
Secondary	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.	six months