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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: NCT03712215
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Universidade do Estado do Pará
Information provided by (Responsible Party):
Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Other: Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: Experimental Group 1
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
diaphragmatic electrical stimulation

Experimental: Experimental Group 2
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
diaphragmatic electrical stimulation

No Intervention: Control Group
The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy

Primary Outcome Measures :
  1. Minute volume [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 24 months ]
    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.

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Individuals aged 60 years and older up to 80 years
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individuals of both sexes aged 60 years and older up to 80 years,
  • in invasive MV for more than 48 hours,
  • with respiratory drive,
  • using MV in the mode of intermittent mandatory synchronized ventilation (VMIS) or (VPS),
  • connected to the orotracheal tube or via tracheostomy,
  • hemodynamically stable,
  • neuromuscular junction of the entire diaphragm,
  • absence of sedatives.

Exclusion Criteria:

  • presence of pacemaker, hyperthermia (temperature> 38 ° C),
  • use of neuromuscular blockers,
  • use of thoracic drains, generalized edema,
  • cutaneous lesion in the area of intervention with TEDS.

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): NCT03712215

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Hospital de Clínicas Gaspar Viana Recruiting
Belém, Pará, Brazil, 66087-660
Contact: Daniel C Torres, Master    +55 91 981291251   
Contact: Rodrigo S Rocha, Doctor    +55 91 992340234   
Sub-Investigator: CARLOS A GOMES, Academic         
Sub-Investigator: GERSON L SOUZA, Academic         
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Universidade do Estado do Pará

Publications of Results:
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Responsible Party: Rodrigo Santiago Barbosa Rocha, Phd, Principal invastigator, Universidade Metodista de Piracicaba Identifier: NCT03712215     History of Changes
Other Study ID Numbers: 1.762.021
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 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:
Mechanical Ventilation
Electrical Stimulation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury