STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

NCT03712215 | Completed

• 1 other identifier: 1.762.021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Mechanical Ventilation; Electrical Stimulation; Diaphragm; Ventilometry; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of randomization until the date of first documented progression, assessed up to 24 months

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

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

Experimental Group 2

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Rehabilitation OTHER

diaphragmatic electrical stimulation

Experimental Group 1; Experimental Group 2

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: Individuals aged 60 years and older up to 80 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Hospital de Clínicas Gaspar Viana

Belém, Pará, 66087-660, Brazil

Location

Related Publications (5)

• Yabek SM, Jarmakani JM. Sinus node dysfunction in children, adolescents, and young adults. Pediatrics. 1978 Apr;61(4):593-8.

  PMID: 662485 RESULT

• 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.

  PMID: 699047 RESULT

• 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.

  PMID: 2306029 RESULT

• 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.

  PMID: 775835 RESULT

• 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.

  PMID: 35040 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invastigator

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: October 19, 2018
• Study Start: September 4, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

BR (1)