Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit

NCT02300662 | Completed DMC

• 1 other identifier: 10-0530
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• change in cross-sectional quadriceps thickness

  ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness

  baseline and after seven days of protocol

Secondary Outcomes (5)

• change in length of fascicle

  baseline and after seven days of protocol

• change in pennation angle of fascicles

  baseline and after seven days of protocol

• change in thickness of vastus lateralis muscle

  baseline and after seven days of protocol

• change in diaphragm thickness

  baseline and after seven days of protocol

• change in diaphragm excursion

  baseline and after seven days of protocol

Study Arms (2)

Cycle Ergometer

EXPERIMENTAL

Conventional physiotherapy and cycle ergometer 20 minutes, at 20 cycles per minute, once per day for as long as they remain on invasive mechanical ventilation

Device: Cycle Ergometer; Other: Conventional physiotherapy

Conventional Physiotherapy

SHAM COMPARATOR

Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.

Other: Conventional physiotherapy

Interventions

Cycle Ergometer DEVICE

Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.

Cycle Ergometer

Conventional physiotherapy OTHER

Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.

Conventional Physiotherapy; Cycle Ergometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of both sexes aged \>= 18 years will be recruited from among those admitted to the Hospital de Clínicas de Porto Alegre intensive care unit and put on invasive mechanical ventilation invasive mechanical ventilation for at least 24 to 48 hours after transfer from the emergency department or wards, no more than 1 week after admission

You may not qualify if:

• neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome.
• patients will also be excluded in the event of the following: extubation less than 48 hours after enrollment on the study
• haemodynamic instability (noradrenaline \> 0.5 mc/kg/min for arterial blood pressure \> 60 mmHg)
• complications during the protocol such as pneumothorax, deep vein thrombosis or pulmonary embolism
• Shilley catheter in the femoral vein
• reintubation
• delayed weaning (3 failed spontaneous ventilation tests)
• body mass index \> 35 kg/m2
• emergence of eschar in the calcaneus area during the protocol.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035 903, Brazil

Location

Related Publications (1)

• dos Santos LJ, de Aguiar Lemos F, Bianchi T, Sachetti A, Dall' Acqua AM, da Silva Naue W, Dias AS, Vieira SR. Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study): study protocol for a randomized controlled trial. Trials. 2015 Aug 28;16:383. doi: 10.1186/s13063-015-0914-8.

  PMID: 26314881 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia R Vieira, ScD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 25, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

BR (1)