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A New Lung Treatment Device for Adult Patients with a Breathing Tube: a Randomized Controlled Clinical Trial

A new Lung Expansion Device for adult Tracheostomized patients: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4bxpkbb
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
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

Tracheostomy

Interventions

Patients in this study will be randomized into two groups, intervention group and control group. Randomization will be carried out using a computer-generated randomization sequence, conducted by an in
They will perform lung ultrasound to control expansion (lung aeration). In the intervention group, the intervention will be performed by a respiratory physiotherapist previously trained to use the pul

Sponsors

Fundação Universidade Federal Do Amapá
Lead Sponsor
Fundação Universidade Federal Do Amapá
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 and over. Hospitalized patients. Patients without impairment of cognition and understanding

Exclusion criteria

Exclusion criteria: Patients requiring invasive mechanical ventilation. Tracheostomy patients due to neuromuscular diseases or spinal cord injury. Patients who withdraw from participating in the study for any reason

Design outcomes

Primary

MeasureTime frame
Assess lung aeration using the Lung Ultrasound Score (LUS) before the first care and after the last care

Secondary

MeasureTime frame
Evaluate the tracheostomy tube indwelling time by recording the tracheostomy cannula in days, from the day of cannula placement until decannulation;Evaluate the length of hospitalization by recording the number of days in which the patient remains hospitalized until hospital discharge;Record the rate of adverse events that occurred in both groups (intervention and control);Record the rate of complications that arise in both groups (intervention and control);Record the need for oxygen supplementation in both groups (intervention and control);Assess peripheral oxygen saturation using a digital oximeter daily for ten minutes until hospital discharge;Assess lung function, forced vital capacity and forced expiratory volume in the first second, using spirometry before the first care and after the last care;Assess respiratory muscle strength using a vacuum gauge before the first service and after the last service;Assess the comfort level of therapy using the visual analogue comfort scale (VASC) after each physiotherapeutic session;Evaluate the usability of the lung expansion device using the system usability scale after each physiotherapeutic session

Countries

Brazil

Contacts

Public ContactLais Bonilha

Comissão Nacional de Ética em Pesquisa

cep@unifap.br+55-96-33121783

Outcome results

None listed

Source: REBEC (via WHO ICTRP)