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Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

Effect of Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05846945
Enrollment
90
Registered
2023-05-06
Start date
2021-08-12
Completion date
2022-07-10
Last updated
2023-05-06

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

Conditions

Respiratory Failure

Brief summary

Ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. Their ages ranged from 50 to 70 years. They were selected from Intensive Care Unit (ICU), Department of Chest Diseases, Cairo University Hospitals. They have randomly assigned into three equal groups. Group (A): trained by threshold IMT device plus routine physical therapy. Group (B): trained by adjusting MV trigger sensitivity plus routine physical therapy. Group (C): only received routine physical therapy. (Negative inspiratory force NIF, arterial blood gases, P/F ration, respiratory rate RR, tidal volume VT, and rapid shallow breathing index RSBI) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).

Interventions

OTHERThreshold inspiratory muscle trainer device

The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.

OTHERAdjusting mechanical ventilator trigger sensitivity

modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure

OTHERChest physiotherapy

Conventional chest physiotherapy

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Their age ranged from 50-70 years. * The patients were diagnosed with acute respiratory failure duo to COPD exacerbation and need mechanical ventilation support for more than 48 hours. * They were vitally stable and can tolerate pressure support * PEEP less than 8Cm H2O , SpO2 more than 90). * All patients were conscious and responded to verbal command.

Exclusion criteria

* Unstable hemodynamics, * unstable neurological problems, * lack of attention and cooperation * skipping more than five training sessions.

Design outcomes

Primary

MeasureTime frameDescription
partial pressure of oxygen(PaO2)change from baseline at one weekarterial blood sample was taken and examined thePao2
partial pressure of carbon dioxide(PaCO2)change from baseline at one weekarterial blood sample was taken and examined the PaCO2

Secondary

MeasureTime frameDescription
Respiratory rate (RR)change from baseline at one weekNumber of respiratory cycles per minute
tidal volume (TV)change from baseline at one weekvolume of air inspired in quiet breathing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026