Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-20 @ 3:54 PM
Study NCT ID:
NCT03815994
Status:
SUSPENDED
Last Update Posted:
2021-02-05
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation in Critically Ill Patients.
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
Status:
SUSPENDED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study had to be suspended due to COVID-19 Pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.
Detailed Description:
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
Study Oversight
Has Oversight DMC:
True
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?: