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

Study Overview
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Brief Summary
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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).

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

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: Threshold inspiratory muscle trainer device
* Other: Adjusting mechanical ventilator trigger sensitivity
* Other: Chest physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IMT group<br>Training by inspiratory muscle device plus chest physiotherapy | Other: Threshold inspiratory muscle trainer device<br>* The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.<br>Other: Chest physiotherapy<br>* Conventional chest physiotherapy<br>|
| Active Comparator: TS group<br>Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy | Other: Adjusting mechanical ventilator trigger sensitivity<br>* modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure<br>Other: Chest physiotherapy<br>* Conventional chest physiotherapy<br>|
| Sham Comparator: PT group<br>Routine chest physiotherapy | Other: Chest physiotherapy<br>* Conventional chest physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial pressure of oxygen(PaO2) | arterial blood sample was taken and examined thePao2 | change from baseline at one week | 
| partial pressure of carbon dioxide(PaCO2) | arterial blood sample was taken and examined the PaCO2 | change from baseline at one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate (RR) | Number of respiratory cycles per minute | change from baseline at one week | 
| tidal volume (TV) | volume of air inspired in quiet breathing | change from baseline at one week |