Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03712215
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2018-09-03
Brief Title:
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
Sponsor:
Universidade Metodista de Piracicaba
Organization:
Universidade Metodista de Piracicaba
Study Overview
Official Title:
ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 220 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 p005 for statistical inferences
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None