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

Respiratory Distress Syndrome Clinical Trial

Official title:

Use of Electrical Impedance Tomography in Children With Syndrome of Acute Respiratory Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768921
• Other study ID #: 78745217.8.0000.5171
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The present study will be developed at the referral hospital in the north of the country, Santa Casa de Misericórdia Foundation of Pará, located at Rua Bernal do Couto 992, Bairro Umarizal, Belém (PA), Unit of Intensive Pediatric Therapy, with the participation of the unit's interdisciplinary team. The data collection period will take place between December 2017 and February 2019.

For the measurement of ventilatory variables (static and regional compliance, regional ventilation, driving pressure, alveolar hyperdistension, alveolar collapse and PEEP titration), the Timpel® Brand Electrical Impedance Tomography monitor will be used to measure hemodynamic variables arterial and oxygen pulse saturation) a DIXTAL® brand monitor will be used.

The instruments used to measure HRV will be the Polar® RS800CX device that features WearLink heart rate sensor, elastic band, contact gel, interface with USB input and a computer.

After the selection and acceptance of the terms of consent and clarification of doubts the research will be carried out in four stages, where the first one will start before performing the alveolar recruitment maneuver; the second, during the alveolar recruitment maneuver; the third, 24 hours after the alveolar recruitment maneuver; and the fourth 48 hours after the alveolar recruitment maneuver. Each of said steps will be divided into sub-steps according to the procedures.

Before the beginning of the alveolar recruitment maneuver, the minor will be sedated and curarized, in order to avoid interference in the recruitment protocol and thus increase the incidence of complications such as increased intrathoracic pressure and consequent alveolar rupture.

Next, the ventilator mechanic flow sensor will be coupled between the child's orotracheal tube that is intubated and the reference sensor on the right flank of the patient's abdomen. The Electrical Impedance Tomography will be connected and observed if all the electrodes are coupled to the patient's chest. At this moment the hemodynamic and ventilatory variables of the study will be collected.

The alveolar recruitment maneuver based on the study of Borges et al. (2006), modified so that PEEP reaches a maximum of 25 cmH2O, with recruitment being performed progressively, as demonstrated in Figure 2, where the pressure variation is maintained at 15 cmH2O and the PEEP increase progressively occurs at 2 cmH2O every 2 minutes, with respiratory rate set at 15 breaths per minute and Ventilatory mode with Controlled Pressure Ventilation ( PCV). 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. This PEEP is maintained for 24 hours so that alveolar recruitment is not lost. The variables will be evaluated again in 24 hours and 48 hours after the alveolar recruitment maneuver to identify the benefits of the same.

For the collection of the modulation will be performed the analysis of the HRV where initially the electrodes of the elastic strip will be moistened with contact gel, then the WearLink sensor will be connected to the band that will be positioned around the patient's chest, just below the pectoral muscles and the hook will be attached to the other end of the strip, subsequently the length of the strip will be adjusted so that the strip is juxtaposed to the skin, yet comfortable. It will be checked if the wetted areas of the electrodes are in contact with the skin and if the Polar logo on the connector is centered and straight. The volunteer will then be placed in the supine position, his / her Systemic Arterial Pressure (BP) will be measured, and then the patient will be advised not to talk, sleep, move his arms or cough during the test.

Once the above procedures have been completed, the R-R intervals will be captured, which will last 10 minutes, where the FR will be marked every minute. At the end, BP will be measured again in the supine position. Then the RS800CX interface will be placed in the computer's USB port and the sensor will be placed next to it for infrared data capture. In this way the data will be downloaded and stored with the patient's name and the day of collection in the Softwere Polar ProTreiner 5. Then the data will be transformed into .txt format and submitted to the Kubios HRV 2.2 softwere software to analyze the heart rate variability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	Fundação Santa Casa de Misericórdia do Pará	Belém	Pará

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Universidade do Estado do Pará

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Donoso F A, Arriagada S D, Díaz 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. Review. Spanish. — View Citation

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 Pu — View Citation

Kheir JN, Walsh BK, Smallwood CD, Rettig JS, Thompson JE, Gómez-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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving pressure	The driving pressure, which indicates alveolar pressure variation and alveolar distension capacity, will be evaluated.	evaluation during two days
Primary	Alveolar collapse	the percentage of alveolar collapse, which indicates how much the pulmonary alveolus is without air.	evaluation during two days
Primary	Alveolar hiperdistension	the percentage of hyperdistended alveoli, which indicates that the alveoli are with excess air in their interior.	Evaluation during two days
Primary	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