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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919085
Other study ID # 01110031483
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2017

Study information

Verified date August 2021
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To analyze changes on respiratory muscle strength, peripheral and functional capacity of critically ill patients with clinical and surgical etiology, breathing spontaneously and bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are correlations among these variables. This is an observational study. Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council score (MRC) and hand grip test and functional capacity through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified according to clinical and surgical characteristics. Correlations will be determined using the Pearson test, with significance level of p <0.05.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Breathing spontaneously - Length of stay in ICU greater than 24 hours - Adherence to study Exclusion Criteria: - Patients with poor prognosis or palliation; - Preexisting neuromuscular diseases; - Immobility or restriction to bed prior to admission; - Nonunions and amputations; - Osteomioarticular, cognitive or neurological impairment; - Non-cooperation; - Specific contraindications to the application of evaluation methods; - Hemodynamic or respiratory instability within 48 hours of ICU admission preventing evaluation muscle strength and functional capacity.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Early ambulation
Procedure to accelerate the ability of a patient to walk or move about by reducing the time to ambulation. It is characterized by a shorter period of hospitalization or recumbency than is normally practiced.

Locations

Country Name City State
Brazil Real Hospital Português de Beneficência Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Neideen T. Monitoring devices in the intensive care unit. Surg Clin North Am. 2012 Dec;92(6):1387-402. doi: 10.1016/j.suc.2012.08.010. Epub 2012 Oct 13. Review. — View Citation

Rossi PJ, Edmiston CE Jr. Patient safety in the critical care environment. Surg Clin North Am. 2012 Dec;92(6):1369-86. doi: 10.1016/j.suc.2012.08.007. Epub 2012 Oct 6. Review. — View Citation

Williams TA, Dobb GJ, Finn JC, Webb SA. Long-term survival from intensive care: a review. Intensive Care Med. 2005 Oct;31(10):1306-15. Epub 2005 Aug 24. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory muscle strength Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP). 48 hours
Primary Peripheral muscle strength The peripheral muscle strength will be assessed through the Medical Research Council score (MRC) and hand grip test. 48 hours
Primary Functional capacity The functional capacity will be assessed through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s). 48 hours
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