Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases

Study Overview
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Brief Summary
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The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.

Detailed Description
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Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations. Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.

Official Title
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Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail

Conditions
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Guillain-Barre Syndrome

Intervention / Treatment
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* Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019). Age: >18 years. Both sexes will be included. Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate < 25. Conscious oriented patient with Glasgow coma score ≥13. Alertness will be titrated to a Riker Sedation Agitation Score of 4. PH>7.25, arterial oxygen saturation >90%. Cardiovascular stability. Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator. Exclusion Criteria: Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure. Severe breathlessness, when spontaneously breathing. Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course). Spinal cord injury. Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs. Patients on heavy sedation and respiratory muscle paralysis. High peak airway pressure (barotraumas). BMI ≥ 40.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Threshold inspiratory muscle trainer<br>Training of the inspiratory muscles by threshold inspiratory muscle trainer. | Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques<br>* New techniques to train inspiratory muscles in mechanically ventilated patients<br>|
| Experimental: Ventilator pressure setting inspiratory muscle training<br>Training of the inspiratory muscles by ventilator pressure setting. | Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques<br>* New techniques to train inspiratory muscles in mechanically ventilated patients<br>|
| No Intervention: Traditional treatment<br>Only prescribed medical treatment programme | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PH | To measure PH | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| PaO2 | To measure partial pressure of oxygen | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| PaCO2 | To measure partial pressure of carbon dioxide | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| HCO3 | To measure bicarbonate | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid shallow breathing index | To measure respiratory endurance | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| The Horowitz index | To measure PaO2 /FiO2 ratio | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| Glasgow coma scale | To measure level of consciousness | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| Riker Sedation-Agitation Scale | Arousal/sedation assessment | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| Respiratory rate | Number of breath cycles per minute | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| Minute ventilation | The amount of air that enters the lungs per minute. | Pre intervention and immediate post intervention, through study completion, an average of two weeks | 
| Weaning success rate | Number of patients weaning from MV | post intervention at the end of the study, an average of two weeks |