Gastroplasty and Electrical Impedance Tomography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Alveolar Recruitment Maneuver

Group Type EXPERIMENTAL

Alveolar Recruitment Maneuver

Intervention Type PROCEDURE

Patients in the Experimental Group will be submitted to ARM, immediately after abdominal desinflation of the pneumoperitoneum (PNP). The ARM will be performed with PEEP of 15 cmH2O for thirty seconds, 20 cmH2O for thirty seconds, 25 cmH2O for thirty seconds, 30 cmH2O for one minute and a inspiratory plateau pressure of 15 cmH2O above PEEP, totaling two minutes and thirty seconds.The data of the TIE will be continuously recorded and the hemodynamic and respiratory function variables such as heart rate (HR), respiratory rate (RF), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) and final gas expiratory pressure carbon dioxide (PETCO2) will be recorded in several moments: immediately after the monitoring, and the patient is still on spontaneous ventilation, 5min after orotracheal intubation, after the installation of the pneumoperitoneum, before and after the execution of the MRA and in the Post-OP, in the first 24h, along with new lung function tests.

Conventional mechanical ventilation

Group Type ACTIVE_COMPARATOR

Conventional mechanical ventilation

Intervention Type PROCEDURE

Immediately after intubation, patients will undergo mechanical ventilation with the ventilator (Dixtal DX 5020) in volume controlled mode with an ideal tidal volume of 7 ml / kg body weight, a set frequency to maintain a carbon dioxide of 35-42 mmHg, and an inspiratory / expiratory ratio of 1: 2. The inspiratory oxygen fraction (FIO2) will be 0.5.

Interventions

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Alveolar Recruitment Maneuver

Patients in the Experimental Group will be submitted to ARM, immediately after abdominal desinflation of the pneumoperitoneum (PNP). The ARM will be performed with PEEP of 15 cmH2O for thirty seconds, 20 cmH2O for thirty seconds, 25 cmH2O for thirty seconds, 30 cmH2O for one minute and a inspiratory plateau pressure of 15 cmH2O above PEEP, totaling two minutes and thirty seconds.The data of the TIE will be continuously recorded and the hemodynamic and respiratory function variables such as heart rate (HR), respiratory rate (RF), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) and final gas expiratory pressure carbon dioxide (PETCO2) will be recorded in several moments: immediately after the monitoring, and the patient is still on spontaneous ventilation, 5min after orotracheal intubation, after the installation of the pneumoperitoneum, before and after the execution of the MRA and in the Post-OP, in the first 24h, along with new lung function tests.

Intervention Type PROCEDURE

Conventional mechanical ventilation

Immediately after intubation, patients will undergo mechanical ventilation with the ventilator (Dixtal DX 5020) in volume controlled mode with an ideal tidal volume of 7 ml / kg body weight, a set frequency to maintain a carbon dioxide of 35-42 mmHg, and an inspiratory / expiratory ratio of 1: 2. The inspiratory oxygen fraction (FIO2) will be 0.5.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No