ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastroplasty and Electrical Impedance Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03476863
Recruitment Status : Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Antonio Christian Evangelista Gonçalves
Armèle Dornelas de Andrade
Norma Sueli Pinheiro Módolo
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastropathy Procedure: Alveolar Recruitment Maneuver Procedure: Conventional mechanical ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 23, 2018
Estimated Primary Completion Date : March 24, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Alveolar Recruitment Maneuver Procedure: 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.

Active Comparator: Conventional mechanical ventilation 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.




Primary Outcome Measures :
  1. Pulmonary aeration by electrical impedance tomography [ Time Frame: 2 days ]

    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. regional pulmonary ventilation by measuring the electrical impedance variation [ Time Frame: 2 days ]

    The TIE will evaluate the behavior of regional pulmonary ventilation by measuring the electrical impedance variation (ΔZ = 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.



Secondary Outcome Measures :
  1. Pulmonary Function [ Time Frame: 2 days ]

    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. Respiratory Muscle Strength [ Time Frame: 2 days ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476863


Contacts
Contact: Antonio Goncalves, anesthesiologist +5581992593476 antoniochristian@hotmail.com
Contact: Daniella Brandão, PhD +5581981359335 daniellacunha@hotmail.com

Sponsors and Collaborators
Daniella Cunha Brandao
Antonio Christian Evangelista Gonçalves
Armèle Dornelas de Andrade
Norma Sueli Pinheiro Módolo

Additional Information:
Publications of Results:
Responsible Party: Daniella Cunha Brandao, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03476863     History of Changes
Other Study ID Numbers: Gastro01
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No