An interventional study of Rehabilitation in Respiratory Distress Syndrome, Adult, sponsored by Universidade Metodista de Piracicaba. Completed at 1 site in Brazil. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Universidade Metodista de Piracicaba · Not applicable, Interventional, and Treatment
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Universidade Metodista de Piracicaba is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
synchronized FES mode, according to the parameters based on the Gueddes et al., (1991): current frequency (F) 30 Hz; pulse width (T) 0,4 ms; upload time (Rise) 1s; time of muscle contraction (On time) 1 s; down time (Decay) 2s e muscle relaxation time (Off time) 1 s.
Other: Rehabilitation
the same apparatus will be used, differing in the parameters that will be based on the studies of Cancelliero et al., (2012) for the EDET procedure, being used in synchronized FES mode, with frequency of 30 Hz; pulse width (T) 0,4 ms, climb (ramp) of 0,7 s (maximum value). The support was of 0.4 s, already standardized and fixed in the apparatus
Other: Rehabilitation
The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy
diaphragmatic electrical stimulation
Minute volume
For the evaluation of the minute volume will be used Wright analog breathing apparatus. This analysis will occur during the initial evaluation and at the end of each service. For measurement, the ventilometer will be connected to a filter of the brand HMEF UNDIS MEDICAL for adults with extensible trachea of 15 cm, and it is attached directly to the tracheostomy cannula. The patient will remain for a maximum of one minute outside the MV, obstructing the nose with nose clip to thus measure the minute volume spontaneously.
Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months
Plan to share: Undecided
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Universidade Metodista de Piracicaba