Comparing two methods to improve breathing in patients with Guillain-Barre Syndrome on ventilators

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

This study is testing two different methods to help patients with Guillain-Barre Syndrome who are on ventilators breathe better and potentially come off the machines more easily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 20 Years to 55 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06167239 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effects of ventilator trigger sensitivity adjustment and threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients suffering from Guillain-Barre Syndrome. The research addresses the challenge of failed extubations, which can lead to increased morbidity and longer hospital stays. By evaluating these two training methods, the study seeks to determine which approach is more effective in facilitating the weaning process from mechanical ventilation. The study will include patients who have been on mechanical ventilation for at least 48 hours and have difficulty weaning.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with Guillain-Barre Syndrome who have been on mechanical ventilation for at least 48 hours and have difficulty weaning.

Not a fit: Patients with persistent hemodynamic instability or severe cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved weaning strategies for patients with Guillain-Barre Syndrome, reducing the risk of failed extubations and associated complications.

How similar studies have performed: While many studies have explored inspiratory muscle training and ventilator adjustments separately, this comparative approach is relatively novel.

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.

Where this trial is running

Cairo

• Kasr Al Ainy School of Medicine — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Elmasry

Conditions Guillain-Barre Syndrome