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Ventilatory Monitoring in Children With Respiratory Distress Syndrome With 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. Identifier: NCT03768921
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Universidade do Estado do Pará
Information provided by (Responsible Party):
Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Brief Summary:
INTRODUCTION: Electrical impedance tomography is a tool for noninvasive monitoring of pulmonary ventilation in real time, which is used during alveolar recruitment maneuvers in patients with acute respiratory distress syndrome. OBJECTIVES: To identify ventilatory and hemodynamic changes during the alveolar recruitment maneuver in children with acute respiratory distress syndrome using electrical impedance tomography. METHODS: Twenty children, aged 4 to 12 years, who present a diagnosis of respiratory distress syndrome, with indication of alveolar recruitment admitted to the Pediatric Intensive Care Unit of the Santa Casa de Misericórdia Foundation of Pará will be selected. Data collection will consist of three before the alveolar recruitment maneuver, immediately after the alveolar recruitment maneuver, 2 hours after the alveolar recruitment maneuver, where the pulmonary ventilation distribution, the driving pressure, the real-time reading compliance will be analyzed. tomography of the Timpel brand, autonomic heart rate modulation through the Polar® RS800CX device, physiological variables such as heart rate, oxygen pulse saturation and blood pressure by measuring the DIXTAL multi-parameter monitor, blood oxygen pressure and the oxygen content dog. The statistical analysis will be performed in the Biostat 5.2 program, and the choice of tests will depend on the types of distributions found and the homogeneity of the respective variances.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Other: PEEP Titriation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The research design is a longitudinal, quantitative and analytical clinical trial.
Primary Purpose: Supportive Care
Official Title: Use of Electrical Impedance Tomography in Children With Syndrome of Acute Respiratory Disorder
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: PEEP Titriation
patients with respiratory distress syndrome will undergo alveolar recruitment in the mechanical ventilator and will have their final positive mechanical ventilator pressure determined by ventilator evaluation by the electrical impedance tomograph. The increase of the peep in the mechanical ventilator to perform the alveolar recruitment will be of 2 in 2 cmH2O every 2 minutes until the pressure reaches 25 cmH20, after the pressure was reduced in the same way being evaluated in the tomograph what will be the point with greater alveolar recruitment, having greater ventilation, without alveolar hyperdistension or alveolar collapse.
Other: PEEP Titriation
The alveolar recruitment maneuver PEEP reaches a maximum of 25 cmH2O, with recruitment being performed progressively, where the pressure variation is maintained at 15 cmH2O and the PEEP increase progressively occurs at 2 cmH2O every 2 minutes and Ventilatory mode with Controlled Pressure Ventilation. After the alveolar recruitment maneuver, the PEEP titration or determination will be performed, where the PEEP of 2 cmH2O will be reduced every 2 minutes and the variables after the alveolar recruitment maneuver and PEEP maintenance will be checked in the TIMPEL brand equipment at the point where the patient has better alveolar recruitment, with fewer alveolar collapsing points and pulmonary hyperdistension.

Primary Outcome Measures :
  1. Driving pressure [ Time Frame: evaluation during two days ]
    The driving pressure, which indicates alveolar pressure variation and alveolar distension capacity, will be evaluated.

  2. Alveolar collapse [ Time Frame: evaluation during two days ]
    the percentage of alveolar collapse, which indicates how much the pulmonary alveolus is without air.

  3. Alveolar hiperdistension [ Time Frame: Evaluation during two days ]
    the percentage of hyperdistended alveoli, which indicates that the alveoli are with excess air in their interior.

  4. Regional air ventilation [ Time Frame: Evaluation during two days ]
    Regional air ventilation, which indicates how air is distributed in the lung, demonstrating the most ventilated and least ventilated areas in the lung.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of ARDS, aged 7 to 12 years;
  • Indication of treatment with alveolar recruitment maneuver.

Exclusion Criteria:

  • Clinical condition that does not allow alveolar recruitment maneuvers
  • Severe hypotension
  • Cardiac arrhythmia
  • Pneumothorax
  • Pneumatocele untreated.

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 identifier (NCT number): NCT03768921

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Fundação Santa Casa de Misericórdia do Pará Recruiting
Belém, Pará, Brazil, 66.050-380
Contact: Paulo E Avila, Doctor    +55 91 981291251   
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Universidade do Estado do Pará
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Principal Investigator: Rodrigo S Rocha, Phd Universidade do Estado do Pará

Publications of Results:
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Responsible Party: Rodrigo Santiago Barbosa Rocha, Phd, Department of Movement Human Sciences Coordinator, Universidade Metodista de Piracicaba Identifier: NCT03768921     History of Changes
Other Study ID Numbers: 78745217.8.0000.5171
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba:
Respiration, Artificial
Intensive Care Units
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases