NCT03712215

STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

Completed NA Last updated 13 August 2020

What this trial tests

NA trial testing Rehabilitation in Respiratory Distress Syndrome, Adult in 30 participants. Completed in 31 January 2019.

Timeline

4 September 2018

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Universidade Metodista de Piracicaba
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	4 September 2018
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Rehabilitation

Conditions studied

• Respiratory Distress Syndrome, Adult — all drugs for Respiratory Distress Syndrome, Adult →

Sponsor

Universidade Metodista de Piracicaba

Who can join

Adults 60 to 80, any sex, with Respiratory Distress Syndrome, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical, longitudinal, prospective, quantitative, single center trial will be performed with 30 (thirty) participants in invasive mechanical ventilatory support, randomly divided into three groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify if the TEDS application interferes with the hemodynamic variables of these patients. The data collected will be linked to Microsoft Office Excel® 2010 software and later transformed into tables and graphs. The information collected will be submitted to statistical analysis through the statistical package SPSS 22.0, applying the descriptive statistics for the characterization of the sample and then selecting the specific tests for the respective variances, adopting a level of significance of p≤0.05 for statistical inferences.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.