Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758052
Status:
WITHDRAWN
Last Update Posted:
2021-06-09
First Post:
2021-02-04
Brief Title:
Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement
Sponsor:
University of Mississippi Medical Center
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
Bedside Gastrostomy With Simultaneous Tracheostomy Effect On Outcomes Of Neurocritically-Ill Patients Proof Of Concept Study
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator change in institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEGASTON
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
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 studiesThe 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 decisionsThere 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
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 decisionsThere 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None