Clinical trial NCT06226428: Cyclo-Ergometry in the Patient With Acute Respiratory Distress Syndrome
Official title: Ciclo-Ergometría en el Paciente Con Síndrome de Distrés Respiratorio Agudo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus
Keywords: Corticosteroids
Mobilization
Oxygenation
Cyclo-ergonometry
Acquired muscle weakness of the critically ill patient
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled pilot clinical trial, with randomized assignment to two treatment groups, the cyclo-ergometry program group and the usual treatment group (parallel). The randomization will be carried out by blocks and will be kept in the Clinical Epidemiology Unit. When the physician has a patient available to enter the study, a call will be made to the Clinical Epidemiology Service where a randomization code and the group to which he/she has been assigned will be indicated.
Primary purpose: SUPPORTIVE_CARE

Brief summary: In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD). IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome.

Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.

Detailed description: In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD).

IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome. Each additional day of bed rest is associated with a 3 to 11% decrease in the strength of both peripheral and respiratory muscles, which translates into difficulty in weaning from mechanical ventilation, longer stay in the Intensive Care Unit and in the hospital in general, as well as an increase in morbidity and mortality. Similarly, in the first 24 hours after initiation of mechanical ventilation, diaphragmatic atrophy or dysfunction occurs, predisposing to prolonged mechanical ventilation. The need for ventilatory support for more than 48 hours has been associated with greater morbidity and mortality at hospital discharge, and survivors present greater disability and deterioration in their quality of life.

Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Most of the programs described in the literature include patients requiring extracorporeal membrane oxygenation, mainly in the pre-transplantation situation, and to a lesser extent patients with acute respiratory distress syndrome. They are characterized by the individual and progressive performance of functional activities of lesser to greater difficulty, starting with passive exercises of joint range, active and active-resisted exercises while the patients are in decubitus, progressing in some cases to sitting at the edge of the bed and less frequently to standing.

Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older
* Alert and cooperative (RASS agitation-sedation between -1 and +1).
* Able to give informed consent (or authorize a family member) to be randomly assigned to receive the cyclo-ergometry program or conventional physiotherapy treatment.
* With or without connection to mechanical ventilation (via orotracheal tube or tracheostomy).
* Clinically stable (cardio-vascular, respiratory, neurological).
* With an inspired oxygen fraction less than or equal to 0.6 and requiring minimal ventilatory support (positive end-expiratory pressure less than or equal to 10 cm H2O).

Exclusion Criteria:

- Patients with pre-existing neuromuscular disease, spinal cord injury, cardiorespiratory arrest, stroke, patients with contraindications for mobility, pregnant women, advanced dementia or patients with life expectancy of less than 6 months or any situation that contraindicates the performance of cycloergometry.

Primary outcomes:
measure: CLINICAL ENDPOINT Age: Years completed at the time of inclusion in the study.
timeFrame: Until discharge from the intensive care unit
measure: CLINICAL ENDPOINT Sex: Dichotomous qualitative variable
timeFrame: Until discharge from the intensive care unit
measure: CLINICAL ENDPOINT Length of stay in the Intensive Care Unit: Number of days elapsed between admission and discharge from Intensive Care.
timeFrame: Until discharge from the intensive care unit
measure: CLINICAL ENDPOINT Overall length of stay in hospital: Number of days between admission and discharge.
timeFrame: Until discharge from the intensive care unit
measure: CLINICAL ENDPOINT Mechanical ventilation time:Number of days between intubation and successful weaning (defined as 48 hours of spontaneous breathing).
timeFrame: Until discharge from the intensive care unit
measure: CLINICAL ENDPOINT Adverse events: Defined as the presence during or within 10 minutes of cyclo-ergometry of any of the following.
timeFrame: Until discharge from the intensive care unit
measure: FUNCTIONAL ENDPOINT Gait capacity: Measured by the 6-minute walk test at the time of discharge from hospital. A simple and inexpensive physical capacity test.
timeFrame: Until discharge from the intensive care unit
measure: FUNCTIONAL ENDPOINT Functional capacity: Measured at discharge from the Intensive Care Unit and at hospital discharge.
timeFrame: Until discharge from the intensive care unit
measure: FUNCTIONAL ENDPOINT Peripheral muscle strength on admission-discharge from ICU and hospital discharge.
timeFrame: Until discharge from the intensive care unit
measure: FUNCTIONAL ENDPOINT ICU MOBILITY SCALE (Spanish adaptation)
timeFrame: Until discharge from the intensive care unit
measure: FUNCTIONAL ENDPOINT Modified Borg Scale
timeFrame: Until discharge from the intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Asociación Instituto Biogipuzkoa
state: Guipuzcoa
Study officials:
References: