Ventilatory Monitoring in Children With Respiratory Distress Syndrome With Electrical Impedance Tomography

NCT03768921 | Completed DMC

• 1 other identifier: 78745217.8.0000.5171
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

Dyspnea; Respiration, Artificial; Intensive Care Units

Outcome Measures

Primary Outcomes (4)

• Driving pressure

  The driving pressure, which indicates alveolar pressure variation and alveolar distension capacity, will be evaluated.

  evaluation during two days

• Alveolar collapse

  the percentage of alveolar collapse, which indicates how much the pulmonary alveolus is without air.

  evaluation during two days

• Alveolar hiperdistension

  the percentage of hyperdistended alveoli, which indicates that the alveoli are with excess air in their interior.

  Evaluation during two days

• Regional air ventilation

  Regional air ventilation, which indicates how air is distributed in the lung, demonstrating the most ventilated and least ventilated areas in the lung.

  Evaluation during two days

Study Arms (1)

PEEP Titriation

EXPERIMENTAL

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

Interventions

PEEP Titriation OTHER

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.

PEEP Titriation

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Fundação Santa Casa de Misericórdia do Pará

Belém, Pará, 66.050-380, Brazil

Location

Related Publications (5)

• Hamm LF, Wenger NK, Arena R, Forman DE, Lavie CJ, Miller TD, Thomas RJ. Cardiac rehabilitation and cardiovascular disability: role in assessment and improving functional capacity: a position statement from the American Association of Cardiovascular and Pulmonary Rehabilitation. J Cardiopulm Rehabil Prev. 2013 Jan-Feb;33(1):1-11. doi: 10.1097/HCR.0b013e31827aad9e.

  PMID: 23254246 RESULT

• Yehya N, Thomas NJ. Disassociating Lung Mechanics and Oxygenation in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2017 Jul;45(7):1232-1239. doi: 10.1097/CCM.0000000000002406.

  PMID: 28350644 RESULT

• Ward SL, Quinn CM, Valentine SL, Sapru A, Curley MA, Willson DF, Liu KD, Matthay MA, Flori HR. Poor Adherence to Lung-Protective Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2016 Oct;17(10):917-923. doi: 10.1097/PCC.0000000000000903.

  PMID: 27513687 RESULT

• Kheir JN, Walsh BK, Smallwood CD, Rettig JS, Thompson JE, Gomez-Laberge C, Wolf GK, Arnold JH. Comparison of 2 lung recruitment strategies in children with acute lung injury. Respir Care. 2013 Aug;58(8):1280-90. doi: 10.4187/respcare.01808. Epub 2012 Dec 4.

  PMID: 23232733 RESULT

• Donoso F A, Arriagada S D, Diaz R F, Cruces R P. [Ventilation strategies in the child with severe hypoxemic respiratory failure]. Gac Med Mex. 2015 Jan-Feb;151(1):75-84. Spanish.

  PMID: 25739487 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Dyspnea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Rodrigo S Rocha, Phd

  Universidade do Estado do Pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The research design is a longitudinal, quantitative and analytical clinical trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Movement Human Sciences Coordinator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: January 10, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

BR (1)