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STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03712215
Enrollment
30
Registered
2018-10-19
Start date
2018-09-04
Completion date
2019-01-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Mechanical Ventilation, Electrical Stimulation, Diaphragm, Ventilometry, Physiotherapy

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.

Interventions

OTHERRehabilitation

diaphragmatic electrical stimulation

Sponsors

Universidade do Estado do Pará
CollaboratorOTHER
Universidade Metodista de Piracicaba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Minute volumeFrom date of randomization until the date of first documented progression, assessed up to 24 monthsFor 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026