Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement (BEGASTON)

Bedside Gastrostomy With Simultaneous Tracheostomy Effect On Outcomes Of Neurocritically-Ill Patients (Proof Of Concept Study)

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.

Study Overview

• Status: Withdrawn
• Conditions: Cerebrovascular Disorders; Neuromuscular Diseases; Spinal Cord Injuries; Neurologic Injury; Stroke, Acute; Coma; Status Epilepticus; Neurological Injury; TBI
• Intervention / Treatment: Other: Timing of placement

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 non-simultaneous or delayed approach (TDG), among neurocritically-ill patients have been reported by various case series and retrospective cohort studies.The timing of tracheostomy generally among neurocritically-ill patients varies from early <5 days or late >7 -10 days. There are currently no guidelines specifically on neurocritically-ill patients and the timing of gastrostomy placement however, it is generally recommended to wait 2-3 weeks as a time limited trial however, there are patients that are able to leave the hospital with the main limitation as being the feeding access. Although it has been suggested to consider tracheostomy to become an indication for gastrostomy this has not been widely accepted although there is an increase in awareness of the TSG approach especially in patients with neurologic conditions.

Tracheostomy have been traditionally indicated include airway obstruction associated with infection, malignancy, injury, sleep apnea and vocal cord dysfunction, prolonged intubation, facilitate weaning from mechanical ventilation, pulmonary hygiene and aspiration.

Gastrostomy tubes have been considered as standard of care for patients requiring alternate forms of long-term enteral feeding. Other indications include long-term nutrition support associated with neurologic or spinal cord deficits, primary swallowing dysfunction, facial or pharyngeal injuries, malignancy of the head and neck and the esophagus, gastric decompression. Approaches available to perform tracheostomy include open, percutaneous tracheostomy, percutaneous dilatational tracheostomy (PDT); Percutaneous Radiologic Tracheostomy and percutaneous ultrasound tracheostomy. Gastrostomy is a temporary or permanent controlled fistula from the lumen of the stomach to the skin. For gastrostomy, approaches include open surgical gastrostomy (SG) or Stamm gastrostomy, Percutaneous endoscopic gastrostomy (PEG), Percutaneous Radiologic gastrostomy (PRG) and Percutaneous Ultrasound gastrostomy (PUG).

In a retrospective cohort study on the outcomes of neurocritically-ill patients who have undergone TSG versus delayed gastrostomy TDG (non-simultaneous tracheostomy and gastrostomy), the patients undergoing TSG had shorter Neurocritical Care Unit (NCCU) length of stay (LOS), hospital LOS, overall hospital cost and higher pre-discharge prealbumin levels. In another study examining the effect of early gastrostomy tube placement on stroke patients, it was found that early gastrostomy tube placement was associated with shorter LOS and higher odds of home or acute rehabilitation discharge disposition. In a retrospective study on intracerebral hemorrhage and subarachnoid hemorrhage patients, it was found that tracheostomy was associated with ICU LOS with almost a 10-day difference if tracheostomy is placed before 7 days or after 14 days. They also found a 6- day difference in overall length of stay between those who had the gastrostomy tubes placed before 7 days or after 14 days. Importantly they saw that the timing of tracheostomy and gastrostomy placement was not associated with mortality. In practice, usual care favors delayed gastrostomy due to availability of imaging resources, proceduralist coordination, and provider preference. Bedside PEG requires the availability of specialized mobile endoscopic equipment and physicians trained in upper endoscopy. In a retrospective study of TSG, among the most common reason for procedural delays were coordination with GI service for performance of PEG. Further, mobile endoscopes are expensive and uncommon across the healthcare system, thus preventing PEG from practical generalizability as an early gastrostomy technique. TSG has been performed using standard PDT and PUG. Because PUG utilizes point-of-care ultrasound (POCUS) technology readily available at the bedside it is a generalizable method for early gastrostomy. Finally, direct comparative evidence to support guidelines for TSG over TDG do not exist. In the absence of clear guidelines, provider preference permits delayed gastrostomy decisions.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. To analyze the effect on patient outcomes of early intervention (TSG versus TDG), a pragmatic randomized clinical trial is needed. 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Christa O'Hana S. Nobleza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: simultaneous tracheostomy with gastrostomy (TSG); This arm include the patients assigned to placement of gastrostomy immediately after tracheostomy.	Other: Timing of placement; Simultaneous placement of tracheostomy and gastrostomy
No Intervention: non-simultaneous or delayed approach tracheostomy and gastrostomy (TDG); This arm include the patients who proceed with "usual care" placement of tracheostomy and gastrostomy as per Neurocritical care Unit service standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital length of stay	total number of midnights a patients is in the hospital for the encounter that the patient	during hospital stay, assessed up to 10 days
nutritional metrics	pre-albumin, albumin, caloric requirements met	up to 14 days before the procedure and up to 14-days before discharge
procedural analgo-sedation used	total dosage of analgo-sedation used	intraprocedure
all-cause mortality	proportion of patients who expired due to all-causes	during hospital stay, assessed up to 10 days
swallow function return	presence, and time to minimal nectar thickened diet is allowed	during hospital stay, assessed up to 10 days
discharge disposition	discharge location (acute rehabilitation, home, LTAC, nursing home, transferred, expired)	during hospital stay, assessed up to 10 days
Functional outcome	Glasgow Outcome Scale Extended, Minimum score =1, Maximum score= 8, lower score is worse	at discharge, assessed up to 6-months
total analgo-sedation dose and duration in the ICU	total analgo-sedation dosages (infusion and boluses)	within ICU-stay, assessed up to 10 days
proportion of ventilator acquired pneumonia before and after procedures	according to updated CDC definition (https://www.cdc.gov/nhsn/PDFs/pscManual/6pscVAPcurrent.pdf)	within ICU stay, assessed up to 10-days
overall ICU and hospital cost	total ICU cost estimated by LOS and severity-derived-diagnosis-related groups [DRG] multiplicator of each patient (Bösel et al., 2013) and total hospital cost at discharge	within in-hospital stay, assessed up to 10-days

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Spinal Cord Diseases; Seizures; Stroke; Wounds and Injuries; Spinal Cord Injuries; Cerebrovascular Disorders; Trauma, Nervous System; Neuromuscular Diseases; Status Epilepticus
• Other Study ID Numbers: 2020V0278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No