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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05955534
Eligibility Criteria:
Inclusion Criteria:
* Informed consent must be obtained from the participant or a Legally Authorized Representative before any trial-specific assessment is performed
* Male or female ≥ 18 years of age
* Participants with Ventilator Dependent Respiratory Failure (VDRF)
* Indication for a bedside percutaneous tracheostomy procedure using an FDA approved percutaneous dilatational tracheostomy device
* Indication for percutaneous gastrostomy including Percutaneous Ultrasound (PUG), Percutaneous Radiologic (PRG), and Percutaneous Endoscopic Gastrostomy (PEG) using an FDA approved gastrostomy kit
* No contraindications to bedside percutaneous tracheostomy OR gastrostomy
* Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization
Exclusion Criteria:
* History of prior gastrostomy, tracheostomy, laryngectomy, gastrostomy prior to tracheostomy decision, known head and neck and gastrointestinal abnormality (cancer, congenital abnormality, anatomic variants).
* Hospitalization \> 21 days at the time of screening
* Known social discharge issues that in the opinion of the investigator will substantially impact the LOS.
* Participants with non-survivable injuries or disease, anticipated life expectancy \< 30 days.
* Uncontrolled coagulopathy
* Contraindications for percutaneous gastrostomy procedures
* Severe Ascites
* Abdominal wall infection at selected site of procedure
* Severe gastroparesis
* Gastric outlet obstruction
* Absolute contraindications to percutaneous dilatational tracheostomy procedure
* Cervical instability
* Infection at the planned insertion site
* Relative contraindications to percutaneous dilatational tracheostomy deemed present by the clinical team
* Difficult anatomy (e.g., short neck, morbid obesity, minimal next extension, or tracheal deviation)
* Severe respiratory disease resulting in inability to withstand periods of apnea or in the loss of positive pressure ventilation
* Pregnancy
* Incongruent goals of care between care team and LAR (family representative).
* Other procedure related concerns by the primary team that would affect safety of the patient.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05955534
Study Brief:
Protocol Section:
NCT05955534