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Bedside Sitting and Respiratory Muscle Training for Critically Ill Intensive Care Unit ICU Patients

Bedside Sedestation and Inspiratory Muscle Training for Critical Intensive Care Unit (ICU) Patients: A Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-93s444p
Enrollment
Unknown
Registered
2024-10-04
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration, Artificial

Interventions

handgrip strength, quadriceps ultrasound, near-infrared spectroscopy every 7 days, sit-to-stand test, and quality of life test at ICU and hospita
E02.760.169.063.500.387
This is a prospective, randomized, interventional, and comparative clinical study. The family members responsible for the patients included in the research will sign the Informed Consent Form after ex

Sponsors

Hospital de Clínicas da Universidade Estadual de Campinas
Lead Sponsor
Hospital de Clínicas da Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age; of both sexes; who have been on invasive mechanical ventilation for a period of 5 days or more will be selected; patients must be hemodynamically stable and on low doses of vasopressor drugs; patients sedated with a Richmond Agitation Sedation Scale (RASS) score between 0 and -2; patients without sedation with a Glasgow Coma Scale score of 9 or higher; patients with adequate gas exchange and stable parameters: positive end-expiratory pressure (PEEP) < 10 cmH2O, inspired oxygen fraction (FiO2) < 0.6, oxygen saturation (SpO2) = 90%

Exclusion criteria

Exclusion criteria: Patients who present the following contraindications for bedside sitting and inspiratory muscle training will be excluded from the study; patients who are hemodynamically unstable and on high doses of vasopressor drugs; patients with worsening gas exchange: inspired oxygen fraction (FiO2) greater than or equal to 0.5; patients with restrictions on changing position: spinal cord injury, increased intracranial pressure, need for logrolling, fractures that prevent sitting at the bedside; participants randomized to the control group, who during hospitalization present a reduction in maximum inspiratory pressure (=30 cmH2O), will be excluded from the study to undergo inspiratory muscle training according to the institutional muscle training protocol

Design outcomes

Primary

MeasureTime frame
From the implementation of the proposed interventions, it is expected to observe not only a reduction in Intensive Care Unit (ICU) and hospital length of stay, but also an improvement in strength, functionality, and diaphragm muscle action in patients undergoing ventilator weaning, as evidenced by a shorter duration of mechanical ventilation use.

Secondary

MeasureTime frame
It is expected that the impairments associated with patients on invasive mechanical ventilation for more than five days will be reduced through vertical positioning and inspiratory muscle training, with the consequent possibility of restoring their activities and vital functions.

Countries

Brazil

Contacts

Public ContactLígia;Gabriela Ratti;de Oliveira

Universidade Estadual de Campinas;Universidade Estadual de Campinas

ligiasroceto@uol.com.br;gabmaoli@gmail.com+55 (19) 35217767;+55 (19) 35217767

Outcome results

None listed

Source: REBEC (via WHO ICTRP)