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

Not Applicable

Recruiting

• Conditions: Guillain-Barre Syndrome
• Interventions: Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques

• Registration Number: NCT06167239
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-12-09
• Study First Posted: 2023-12-12
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. 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).
2. Age: >18 years.
3. Both sexes will be included.
4. Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate < 25.
5. Conscious oriented patient with Glasgow coma score ≥13.
6. Alertness will be titrated to a Riker Sedation Agitation Score of 4.
7. PH>7.25, arterial oxygen saturation >90%.
8. Cardiovascular stability.
9. Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.

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Exclusion Criteria

1. Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
2. Severe breathlessness, when spontaneously breathing.
3. Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
4. Spinal cord injury.
5. Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
6. Patients on heavy sedation and respiratory muscle paralysis.
7. High peak airway pressure (barotraumas).
8. BMI ≥ 40.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventilator pressure setting inspiratory muscle training	Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques	Training of the inspiratory muscles by ventilator pressure setting.
Threshold inspiratory muscle trainer	Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques	Training of the inspiratory muscles by threshold inspiratory muscle trainer.

Primary Outcome Measures

Name	Time	Method
PH	Pre intervention and immediate post intervention, through study completion, an average of two weeks	To measure PH
PaCO2	Pre intervention and immediate post intervention, through study completion, an average of two weeks	To measure partial pressure of carbon dioxide
HCO3	Pre intervention and immediate post intervention, through study completion, an average of two weeks	To measure bicarbonate
PaO2	Pre intervention and immediate post intervention, through study completion, an average of two weeks	To measure partial pressure of oxygen

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasr Al Ainy School of Medicine; 🇪🇬 Cairo, Egypt