Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Launched by PHILIPS PORTUGUESA S.A. · May 25, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how early ventilation, which is a type of breathing support, can affect the recovery of patients who have had their first stroke and also have sleep apnea. Sleep apnea is a condition where breathing stops and starts during sleep, and it can make stroke recovery more challenging. The trial aims to see if starting ventilation soon after a stroke can improve health outcomes one month later.

To be eligible to join this study, participants need to be between 18 and 80 years old, have been admitted to the hospital within 48 hours after their stroke symptoms began, and have a confirmed diagnosis of an ischemic stroke (the most common type of stroke caused by a blockage in a blood vessel). They also need to have sleep apnea that is considered moderate to severe. Participants can expect to receive close monitoring and support during their hospital stay as part of the trial. It's important to note that certain medical conditions, such as severe heart issues or ongoing serious lung problems, would prevent someone from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
• • 2. Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
• • 3. Admission to the hospital within 48 h of stroke symptoms onset.
• • 4. Ischemic first stroke diagnosis.
• • 5. NIHSS ≥2 at screening.
• • 6. Sleep apnea with AHI ≥15.
• Exclusion Criteria:
• • 1. CSA with Left Ventricular Ejection Fraction ⩽45%.
• • 2. Ventilation treatment for sleep apnea diagnosis, prior to stroke.
• • 3. Risk of aspiration.
• • 4. Nasogastric feeding tube.
• • 5. Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
• • 6. Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
• • 7. Cardiorespiratory distress.
• • 8. Advanced chronic lung disease requiring supplemental oxygen.
• • 9. Concomitant central nervous system diseases such as dementia or multiple sclerosis.
• • 10. Uncontrolled psychosis or agitation.
• • 11. Glasgow Coma Scale (GCS) score \<10 at screening.
• • 12. Anosognosia, global or Wernicke aphasia.
• • 13. Insufficient upper limbs function to use a mask and no overnight caregiver to help.
• • 14. Inability to attend to the rehabilitation program of the hospital.
• • 15. Pregnant and breast-feeding women.
• • 16. Participation in another clinical study (except a standard-of-care registry).
• • 17. Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.