Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT00729261
Eligibility Criteria:
Inclusion Criteria:
1. Resolution or improvement of any pulmonary process requiring mechanical ventilation.
2. Adequate gas exchange.
3. Adequate ventilation.
4. Respiratory rate to tidal volume ratio \<105.
5. Core body temperature \< 38 degrees celsius.
6. Hemoglobin \> 8 grams per deciliter.
7. No sedative medications for 2 hours.
Neurological requirements included:
1. GCS ≤ 8.
2. Intracranial pressure (ICP) \< 15 cm of water and a cerebral perfusion pressure (CPP) \> 60 mm Hg for patients with intracranial pressure monitors.
Exclusion Criteria:
1. Age \< 18 years.
2. Lack of informed consent by the patients' surrogate.
3. Dependence on mechanical ventilation for at least two weeks prior to enrollment.
4. Patients with tracheostomies.
5. Intubation instituted for therapeutic hyperventilation.
6. Planned surgical or radiological intervention within the next 72 hours.
7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00729261
Study Brief:
Protocol Section:
NCT00729261