NCT06167239 Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases
| NCT ID | NCT06167239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Guillain-Barre Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2023-05-02 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Elmasry
STUDY DIRECTOR
Cairo University
Frequently Asked Questions
Who can join the NCT06167239 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 55 Years, studying Guillain-Barre Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06167239 currently recruiting?
Yes, NCT06167239 is actively recruiting participants. Contact the research team at egydodo@rocketmail.com for enrollment information.
Where is the NCT06167239 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06167239 clinical trial?
NCT06167239 is sponsored by Cairo University. The principal investigator is Elmasry at Cairo University. The trial plans to enroll 45 participants.