Clinical trial NCT06167239: Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases
Official title: Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Guillain-Barre Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: PH
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: PaO2
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: PaCO2
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: HCO3
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary outcomes:
measure: Rapid shallow breathing index
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: The Horowitz index
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: Glasgow coma scale
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: Riker Sedation-Agitation Scale
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: Respiratory rate
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: Minute ventilation
timeFrame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
measure: Weaning success rate
timeFrame: post intervention at the end of the study, an average of two weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy School of Medicine
Study officials:
affiliation: Cairo University
name: Elmasry
role: STUDY_DIRECTOR
References: