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STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Mechanical Ventilation, Electrical Stimulation, Diaphragm, Ventilometry, Physiotherapy

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas Gaspar Viana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental Group 1

Experimental Group 2

Control Group

Arm Description

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.

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

The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2018
Last Updated
August 11, 2020
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará
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1. Study Identification

Unique Protocol Identification Number
NCT03712215
Brief Title
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
Official Title
ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
Mechanical Ventilation, Electrical Stimulation, Diaphragm, Ventilometry, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
diaphragmatic electrical stimulation
Primary Outcome Measure Information:
Title
Minute volume
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Individuals aged 60 years and older up to 80 years
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital de Clínicas Gaspar Viana
City
Belém
State/Province
Pará
ZIP/Postal Code
66087-660
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
662485
Citation
Yabek SM, Jarmakani JM. Sinus node dysfunction in children, adolescents, and young adults. Pediatrics. 1978 Apr;61(4):593-8.
Results Reference
result
PubMed Identifier
699047
Citation
Wachtel SS, Basrur P, Koo GC. Recessive male-determining genes. Cell. 1978 Sep;15(1):279-81. doi: 10.1016/0092-8674(78)90103-4.
Results Reference
result
PubMed Identifier
2306029
Citation
Geddes LA, Voorhees WD, Bourland JD, Riscili CE. Optimum stimulus frequency for contracting the inspiratory muscles with chest-surface electrodes to produce artificial respiration. Ann Biomed Eng. 1990;18(1):103-8. doi: 10.1007/BF02368420.
Results Reference
result
PubMed Identifier
775835
Citation
Krymskii LD, Nestaiko GV. [Scanning electron microscopy of vessels in normal and pathologic states]. Vestn Akad Med Nauk SSSR. 1975;(11):71-6. No abstract available. Russian.
Results Reference
result
PubMed Identifier
35040
Citation
Arguelles JE, Franatovic Y, Romo-Salas F, Aldrete JA. Intrabiliary pressure changes produced by narcotic drugs and inhalation anesthetics in guinea pigs. Anesth Analg. 1979 Mar-Apr;58(2):120-3.
Results Reference
result

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STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

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