Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement
Withdrawn before enrolling · Not applicable
Conditions studied: Stroke, Acute, TBI, Neuromuscular Diseases, Status Epilepticus, Coma, Cerebrovascular Disorders, Spinal Cord Injuries, Neurological Injury, Neurologic Injury
In brief
There is currently no prospective study analyzing the effect of tracheostomy with bedside simultaneous gastrostomy versus tracheostomy with delayed gastrostomy placement (TSG versus TDG) on the outcomes of neurocritically-ill patients. The investigators will study TSG via concomitant PDT and PUG procedures, while TDG will occur per usual care. This study is a prospective randomized open-label blinded endpoint study to assess the effect of tracheostomy with bedside simultaneous gastrostomy (TSG) versus the usual care of tracheostomy with delayed gastrostomy (TDG) placement on outcomes of neurocritically-ill patients.
Key facts
- Study ID
- NCT04758052
- Run by
- University of Mississippi Medical Center
- People needed
- 0
- Starts
- 2021-03-31
- Expected to finish
- 2022-08-01
- Last updated by the study team
- 2021-06-09
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years old- 85 years old
- Admitted under the NSICU service
- Shared-decision making with surrogate decision maker and primary neuro-intensivist agreement to proceed with tracheostomy and gastrostomy with documented discussion.
- have indications for tracheostomy and gastrostomy
- Subjects or their SDM or legally authorized representative (LARs) must voluntarily provide informed consent prior to the initiation of any study-specific procedure in a form approved by an independent IRB. In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
You may not qualify if…
- Patients who require tracheostomy only or gastrostomy only
- history of prior gastrostomy, tracheostomy, laryngectomy, gastrostomy prior to tracheostomy decision, known head and neck and gastrointestinal abnormality (cancer, congenital abnormality, anatomic variants)
- withdrawal of care, a transfer from another service or hospital if patient has been there for >24hr.
- known social discharge issues anticipating hospital stay >100 days
- Patients with nonsurvivable injuries, anticipated mortality <72 hours
- standard of care contraindications for either bedside tracheostomy and gastrostomy
- Absolute contraindications for gastrostomy: gastric outlet obstruction, significant gastroparesis, significant gastroesophageal reflux, a proximal high-output entercutaneous fistula
- Standard Contraindications for percutaneous gastrostomy technique: ascites, morbid obesity and esophageal and gastric pathology
- Standard Contraindications for either PEG or PUG procedures
- Standard Contraindications to percutaneous dilational tracheostomy: Gross anatomical distortion of the neck, previous neck surgery , burns, radiotherapy, unstable or rigid cervical spine, tracheal distortion, stenosis, or malacia, morbid obesity (BMI >35kg/m2), massive thyroid gland or vessels in the operation field on ultrasound, hemodynamic instability, refractory intracranial hypertension, hemodynamic instability, Coagulopathy (Aptt>50s, INR>1.5, platelet count <50,000μL, emergency need for a tracheostomy or need for a permanent tracheostoma, very difficult airway management
- Pregnancy
- Life expectancy less than three-weeks
- Goals of care disagreement between care team and LAR
- braindead
- LAR preferred procedures placed in LTAC
Where it is running
- Christa O'Hana S. Nobleza — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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