Gastropathy Clinical Trial
Official title:
IMPACT OF ALVEOLAR RECOVERY MANEUVER ON PULMONARY FUNCTION AND RESPIRATORY MECHANISM IN PATIENTS SUBMITTED TO BARIATRIC SURGERY ASSESSED BY ELECTROMAT IMPEDANCE TOMOGRAPHY: A RANDOMIZED CLINICAL TRIAL
| Verified date | July 2020 |
| Source | Universidade Federal de Pernambuco |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Worldwide there is a high prevalence of morbid obesity with a progressive increase in incidence in recent years, causing serious consequences for the health services. Approximately 12% of the world population is obese and Brazil is in 77º without world ranking of countries in cases of obesity. In this context, bariatric surgery appears as an effective method of treating refractory obesity. Support of high fractions of oxygen administered during anesthesia is produced, it accepts the use of Positive Positive Positive Pressure (PEEP) through the Alveolar Recruitment Maneuver (ARM), which has been used allowing small fractions inspired by oxygen, which reduces intra-and postoperative atelectasis and optimizes gas exchange during anesthesia. In order to better monitor ventilatory mechanics, Electrical Impedance Tomography (EIT) appears as a cheap imaging method when compared to a non-invasive magnetic resonance imaging (CT) or MRI, with no side effects and recent studies shown in its life as pneumothorax , MRA monitoring, collapse detection, and PEEP titration. The aim of this study is to evaluate the impact of ARM and its repercussions on lung function and respiratory mechanics. This is a randomized controlled clinical trial with patients undergoing videolaparoscopic gastroplasty surgery, of both sexes. Patients were randomly assigned to Control Group and Experimental Group. Patient evaluation is performed without before, during and postoperative, through a pulmonary function test and EIT.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | December 30, 2019 |
| Est. primary completion date | March 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients submitted to videolaparoscopy gastroplasty surgery, of both sexes Exclusion Criteria: - Severe pneumopathies; - Congestive heart failure (NYHA class III or IV); - Coronary artery disease, and those who, for any clinical, surgical and psychosocial reasons, require intervention by laparotomy and those with hemodynamic instability (PAM) <60 mmHg) at the time recorded for performing the alveolar recruitment maneuver. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Daniella Cunha | Recife |
| Lead Sponsor | Collaborator |
|---|---|
| Daniella Cunha Brandao | Antonio Christian Evangelista Gonçalves, Armèle Dornelas de Andrade, Norma Sueli Pinheiro Módolo |
Brazil,
Meier T, Luepschen H, Karsten J, Leibecke T, Grossherr M, Gehring H, Leonhardt S. Assessment of regional lung recruitment and derecruitment during a PEEP trial based on electrical impedance tomography. Intensive Care Med. 2008 Mar;34(3):543-50. Epub 2007 — View Citation
WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. Review. Erratum in: Lancet. 2004 Mar 13;363(9412):902. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pulmonary aeration by electrical impedance tomography | The TIE will evaluate the behavior of regional pulmonary aeration by measuring the electrical impedance variation throught the mean electrical impedance at the end of expiration (MIEFE) and the mean electric impedance at the end of the (MIEFI). Thirty-two electrodes will be attached circumferentially (equally spaced) around the volunteer's chest, just below the level of the axilla. An electric current of 5 mA will be emitted at 125 KHz by means of a pair of electrodes. The data evaluated by the TIE will be recorded before, during and immediately after performing the maneuvers until the reduction to the baseline values is verified. |
2 days | |
| Primary | regional pulmonary ventilation by measuring the electrical impedance variation | The TIE will evaluate the behavior of regional pulmonary ventilation by measuring the electrical impedance variation (?Z = inspiratory impedance - expiratory impedance) of the distribution of regional pulmonary ventilation in the dependent and nondependent regions of the right and left lungs, and the dynamic compliance of the respiratory system. Thirty-two electrodes will be attached circumferentially (equally spaced) around the volunteer's chest, just below the level of the axilla. An electric current of 5 mA will be emitted at 125 KHz by means of a pair of electrodes. The data evaluated by the TIE will be recorded before, during and immediately after performing the maneuvers until the reduction to the baseline values is verified. |
2 days | |
| Secondary | Pulmonary Function | To measure the spirometric values, 3 maneuvers will be performed according to American Thoracic Society Guidelines recommendations, with the participant sitting comfortably using a disposable mouthpiece and nasal clip, with values of forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), forced expiratory flow 25% -75% (FEF 25% -75%) and the FEV1 / FVC ratio. To perform the tests a portable spirometer (Micro Medical, Microloop, MK8, England) will be used and the values obtained will be interpreted according to the predicted values of Pereira el. al. These variables are being presented together because it is an examination called spirometry. |
2 days | |
| Secondary | Respiratory Muscle Strength | The manovacuometry will be performed according to the recommendations of the American Thoracic Society and the European Respiratory Society (ATS / ERS) and the Brazilian Society of Pulmonology and Physiology (SBPC). The manovacuometry will be performed according to the recommendations of the American Thoracic Society and the European Respiratory Society (ATS / ERS) and the Brazilian Society of Pulmonology and Physiology (SBPC). Therefore, during the collection of MIP and MEP values, with the arms free and will be oriented to attach to your mouth a nozzle (type diver) with presence of leakage hole of 2mm of internal diameter. The individual will be instructed to perform a maximum expiration and maximal inspiration for at least 1,5s, so that the maximum sustained pressure for one second is observed (maximum mean pressure) in the manovacuometer MVD 300, Globalmed, Brazil. |
2 days |