Rehabilitation of Critically Ill Patients With SARS-CoV-2 Variants in ICU With Limited Resources

NCT05450120 | Unknown DMC

• 1 other identifier: 07351119.2.0000.5381
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. Scientific evidence has considered neuromuscular electrical stimulation (NMES) as a promising approach for the early rehabilitation of patients during and/or after ICU. Neuromuscular electrostimulation can be an alternative form of muscle exercise that helps to gain strength in critically ill patients with COVID -19, due to the severe weakness that patients experience due to longer MV, analgesia and NMB duration. Thus, the general objective of evaluating the effects of an early rehabilitation protocol on the strength and functionality of patients affected by SARS-CoV-2 variants and specifically compare the effectiveness of NMES associated with the functional rehabilitation protocol(FR). Also, describe demographics, clinical status, ICU therapies, mortality estimates and Hospital outcomes, of every patients admitted in ICU during the observation periods.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

COVID-19; intensive care unit; early mobilization; rehabilitation; electrical stimulation; muscle weakness

Outcome Measures

Primary Outcomes (2)

• Skeletal muscle strength

  Improved skeletal muscle strength by modified Medical Research Council (mMRC)

  5 months

• Functional independence

  Improved level of functional independence by ICU Mobility Scale (IMS) and Functional Status Score for the ICU (FSS-ICU)

  5 months

Secondary Outcomes (2)

• Mechanical ventilation and hospitalization

  5 months

• Survived and discharged

  5 months

Study Arms (2)

Functional Rehabilitation

ACTIVE COMPARATOR

Functional rehabilitation protocol

Other: Functional Rehabilitation

NMES + Functional Rehabilitation

EXPERIMENTAL

Functional rehabilitation protocol associated with neuromuscular electrical stimulation

Other: Functional Rehabilitation; Other: Neuromuscular Electrical Stimulation

Interventions

Functional Rehabilitation OTHER

Functional rehabilitation protocol

Functional Rehabilitation; NMES + Functional Rehabilitation

Neuromuscular Electrical Stimulation OTHER

Neuromuscular electrical stimulation protocol

NMES + Functional Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Subjects admitted in ICU for \>72hs, undergoing orotracheal intubation and on mechanical ventilation for \>48hs, with a diagnosis of Acute Respiratory Distress Syndrome (ARDS) according to Berlin definition secondary to COVID-19, with shock or organ failure, according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (7th Interim Edition) Guideline, and clinical stability:
• mean arterial pressure \< 60 mmHg;
• heart rate \>60 and \<120 beats/minute;
• respiratory rate \<30 breaths/minute;
• oxygen saturation ≥ 92%;
• fraction of inspired oxygen (FiO2) ≤0.6;
• absence of vasopressor dose increase
• absence of dysrhythmia (except for chronic atrial fibrillation);
• controlled sepsis;
• hemoglobin (Hb) \> 8g m/d, plaquettes \>20.000, Glucemia \>70 e \<180;
• without NMBs

You may not qualify if:

• Patients with movement resistance
• Walking without assistance before the ICU (except using a cane)
• Cognitive impairment before acute illness
• Signs of intracranial hypertension, neuromuscular disease (myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré) and stroke; hip fracture, unstable cervical spine, or pathological fracture
• Prior hospitalization (30 days before ICU)
• Readmission to the ICU, within the current hospitalization
• Presence of an implanted cardiac pacemaker or defibrillator, pregnancy, acute myocardial infarction and, for the experimental group (EG), against indications for NMES (deep vein thrombosis, skin lesions, rhabdomyolysis).

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Santa Casa de Batatais

Batatais, São Paulo, 14300-029, Brazil

Location

Related Publications (24)

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  BACKGROUND

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MeSH Terms

Conditions

COVID-19; Muscle Weakness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jacqueline Vianna, Phd

  UFSCAR

  PRINCIPAL INVESTIGATOR

• Jamami, Phd

  UFSCAR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in physical therapy, postdoctoral student Department of Physical Therapy

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: May 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

BR (1)