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

• ClinicalTrials.gov Identifier: NCT04758052
• Recruitment Status: Withdrawn
• First Posted: February 17, 2021
• Last Update Posted: June 9, 2021
• Sponsor: University of Mississippi Medical Center
• Information provided by (Responsible Party): University of Mississippi Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute; TBI; Neuromuscular Diseases; Status Epilepticus; Coma; Cerebrovascular Disorders; Spinal Cord Injuries; Neurological Injury; Neurologic Injury	Other: Timing of placement	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Masking Description: blinded endpoint
• Primary Purpose: Treatment
• Official Title: Bedside Gastrostomy With Simultaneous Tracheostomy Effect On Outcomes Of Neurocritically-Ill Patients (Proof Of Concept Study)
• Actual Study Start Date: March 31, 2021
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: August 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. ICU length of stay [ Time Frame: during hospital stay, assessed up to 10 days ]
   total number of midnights a patient is in the ICU for the duration of their hospital stay

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Mississippi

Christa O'Hana S. Nobleza

Jackson, Mississippi, United States, 39216

Sponsors and Collaborators

University of Mississippi Medical Center

More Information

• Responsible Party: University of Mississippi Medical Center
• ClinicalTrials.gov Identifier: NCT04758052
• Other Study ID Numbers: 2020V0278
• First Posted: February 17, 2021
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Neuromuscular Diseases; Stroke; Status Epilepticus; Cerebrovascular Disorders; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Seizures; Neurologic Manifestations