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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT05387720
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes with age ranges (50-60) years old.
* Patients will be referred with acute respiratory failure (ARF) inside ICU.
* All patients are intubated and mechanically ventilated with assisted control (pressure or volume) or pressure support modes for 24-48 hours.
* All patients with positive end expiratory pressure (PEEP) don't exceed 10 cmH2o.
* All patients are hemodynamically stable; temperature (36.2-37.5) C, Heart rate \< 140 /min, Blood pressure (systolic: \<180mmHg and diastolic \<100 mmHg), Respiratory rate \< 35/min and oxygen saturation \>90%
* All patients are conscious and responsive to verbal command.
Exclusion Criteria:
* Fraction of inspired oxygen (fio2)\>0.6 and SPO2 \< 85% to avoid further hypoxia and respiratory distress.
* Positive end expiratory pressure (PEEP) \> 10 cmH2O to avoid barotrauma.
* Severe pulmonary condition; acute pulmonary embolism, undrained pneumothorax.
* Unstable hemodynamic condition as defined by heart rate more than 140 beats/min, systolic blood pressure \>180 mmHg or Low blood pressure \< 80 mmHg and respiratory rate is exceeding 35 breaths/min.
* Patients who develop any cardiac condition during the course of treatment; acute myocardial infarction or cardiac arrhythmia.
* Patients who recently have undergo cardiac or abdominal or gynecological surgery.
* Active lung infection like tuberculosis.
* Chest trauma such as rib fracture, flail chest, thoracic vertebra fracture or chest burns.
* Spinal cord injuries involved the phrenic nerve.
* Active bleeding as alveolar hemorrhage, hemoptysis.
* Heavy sedation that depresses respiratory drive or ability to follow commands.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
60 Years
Study:
NCT05387720
Study Brief:
Protocol Section:
NCT05387720