STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712215
• Other study ID #: 1.762.021
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2020
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Rehabilitation
diaphragmatic electrical stimulation

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas Gaspar Viana	Belém	Pará

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Universidade do Estado do Pará

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View Citation

Krymskii LD, Nestaiko GV. [Scanning electron microscopy of vessels in normal and pathologic states]. Vestn Akad Med Nauk SSSR. 1975;(11):71-6. Review. Russian. — View Citation

Wachtel SS, Basrur P, Koo GC. Recessive male-determining genes. Cell. 1978 Sep;15(1):279-81. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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