Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement

NCT04758052 | Withdrawn

• 1 other identifier: 2020V0278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke, Acute; TBI; Neuromuscular Diseases; Status Epilepticus; Coma; Cerebrovascular Disorders; Spinal Cord Injuries; Neurological Injury; Neurologic Injury

Outcome Measures

Primary Outcomes (1)

• ICU length of stay

  total number of midnights a patient is in the ICU for the duration of their hospital stay

  during hospital stay, assessed up to 10 days

Secondary Outcomes (10)

• hospital length of stay

  during hospital stay, assessed up to 10 days

• nutritional metrics

  up to 14 days before the procedure and up to 14-days before discharge

• procedural analgo-sedation used

  intraprocedure

• all-cause mortality

  during hospital stay, assessed up to 10 days

• swallow function return

  during hospital stay, assessed up to 10 days

Study Arms (2)

simultaneous tracheostomy with gastrostomy (TSG)

EXPERIMENTAL

This arm include the patients assigned to placement of gastrostomy immediately after tracheostomy.

Other: Timing of placement

non-simultaneous or delayed approach tracheostomy and gastrostomy (TDG)

NO INTERVENTION

This arm include the patients who proceed with "usual care" placement of tracheostomy and gastrostomy as per Neurocritical care Unit service standard.

Interventions

Timing of placement OTHER

Simultaneous placement of tracheostomy and gastrostomy

simultaneous tracheostomy with gastrostomy (TSG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Christa O'Hana S. Nobleza

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Stroke; Neuromuscular Diseases; Status Epilepticus; Coma; Cerebrovascular Disorders; Spinal Cord Injuries; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Spinal Cord Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: blinded endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center prospective randomized open-label blinded endpoint proof-of-concept study to assess the effect of TSG versus usual care TDG placement on outcomes among neurocritically-ill patients.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 17, 2021
• Study Start: March 31, 2021
• Primary Completion: January 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

US (1)