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

NCT02577744 | Unknown

• 1 other identifier: 38032414.3.0000.5208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery; Obesity; Physical Therapy Modalities

Keywords

Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effects of bariatric surgery on respiratory muscle strength

  Six months

• Patient perception of evaluation and assessing the quality of postoperative recovery

  Six months

• Effects of bariatric surgery on lung function

  Six months

• Adverse effects of technical and EPAP NIV

  Six months

• Therapeutic effect time of the EPAP and NIV

  six months

Study Arms (2)

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.

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.

Other: Noninvasive Ventilation; Other: Expiratory Positive Air Pressure

Interventions

Noninvasive Ventilation OTHER

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.

Also known as: NIV

Expiratory Positive Air Pressure; Noninvasive Ventilation

Expiratory Positive Air Pressure OTHER

EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Also known as: EPAP

Expiratory Positive Air Pressure; Noninvasive Ventilation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital das Clínicas

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Sóstynis JA Silva, Mastering

CONTACT

+558199750784; sostynis@bol.com.br

Armele FD Andrade, Doctor

CONTACT

armeledornelas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acute Effect of Epap and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

BR (1)