Status:
WITHDRAWN
Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement
Lead Sponsor:
University of Mississippi Medical Center
Conditions:
Stroke, Acute
TBI
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 outcom...
Detailed Description
The practice of performing tracheostomy and gastrostomy simultaneously has been reported since the 1980s. The safety and feasibility of simultaneous tracheostomy with gastrostomy (TSG), compared to no...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04758052
Start Date
March 31 2021
End Date
August 1 2022
Last Update
June 9 2021
Active Locations (1)
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1
Christa O'Hana S. Nobleza
Jackson, Mississippi, United States, 39216