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Effects and safety of a Lung Expansion Therapy protocol in patients with artificial airway admitted to intensive care units: randomized clinical trial

Efficacy and safety of a Lung Expansion Therapy protocol in tracheostomized patients undergoing spontaneous ventilation in the intensive care unit: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3dncdr5
Enrollment
Unknown
Registered
2024-04-22
Start date
2023-02-10
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

Respiratory fisioterapy

Interventions

This is a randomized, controlled, parallel, unblinded clinical trial with tracheostomized patients, who are on spontaneous ventilation, admitted to two adult General Intensive Care Units (ICU) of a la
the fatigue resistance index (IRF), which predicts the resistance to muscle fatigue when subjected to loads, through the relationship PIMax Final/PIMax initial and the rapid superficial breathing inde
E02.583

Sponsors

Hospital Geral Roberto Santos
Lead Sponsor
Hospital Geral Roberto Santos
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Tracheostomized patients undergoing spontaneous ventilation; age greater than or equal to 18 years; of both sexes; with Maximum inspiratory pressure (PImax) less than minus 30; with pathologies of different etiologies; with prolonged bed rest (more than 14 days); admitted to an intensive care unit

Exclusion criteria

Exclusion criteria: Patients who present progressive worsening of the clinical condition; shock; fracture in the chest region; pneumothorax; Immediate postoperative period of abdominal surgeries

Design outcomes

Primary

MeasureTime frame
It is expected to find a success rate of disconnection from mechanical ventilation at least 30% higher than the control group—

Secondary

MeasureTime frame
Evaluate the safety of the technique through hemodynamic monitoring;Evaluate the incidence of barotrauma during the application of the lung expansion therapy protocol;Compare the length of stay in the intensive care unit in relation to the control group—

Countries

Brazil

Contacts

Public ContactPedro Moreira

Hospital Geral Roberto Santos

pedrodfm01@gmail.com+55 071 988909445

Outcome results

None listed

Source: REBEC (via WHO ICTRP)