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Trial to Reduce Periprocedural Fasting in Ventilated Trauma Patients (PEG)

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ClinicalTrials.gov Identifier: NCT04110613
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Carilion Clinic

Brief Summary:
With this randomized controlled trial, investigators seek to produce data in support of a periprocedural nutrition delivery protocol that results in reduced enteral nutrition interruption (ENI) for critically ill ventilated trauma and surgical intensive care(TSICU) patients. Periprocedural fasting is a frequent culprit of nutrition delivery deficits for this patient population, and percutaneous endoscopic gastrostomy(PEG) tube placement is a common procedure performed at the bedside. Pre- and post-PEG tube placement fasting practices are highly variable. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population.

Condition or disease Intervention/treatment Phase
Critical Illness Malnutrition Gastrostomy Procedural Sequelae Trauma Surgery Dietary Supplement: noFAST group Not Applicable

Detailed Description:
With this randomized controlled trial, investiagtors seek to produce data in support of a periprocedural nutrition delivery protocol that results in reduced enteral nutrition interruption (ENI) for critically ill ventilated trauma and surgical intensive care(TSICU) patients. Periprocedural fasting is a frequent culprit of nutrition delivery deficits for this patient population, and percutaneous endoscopic gastrostomy(PEG) tube placement is a common procedure performed at the bedside. Pre- and post-PEG tube placement fasting practices are highly variable among surgical intensivists. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population. This study will evaluate the effects of implementing an evidence-based truncated fasting protocol for ventilated trauma and surgical intensive care unit patients undergoing the PEG procedure. For clinically indicated reasons, these patients are maintained in a sedated state and supported by a ventilator via a cuffed endotracheal tube. They typically have an orogastric, nasogastric, or nasoduodenal (Dobhoff) feeding tube in place, and have demonstrated tolerance to enteral nutrition delivery prior to being scheduled for clinically indicated PEG tube placement. If they have a nasoduodenal feeding tube, they typically also have a naso- or orogastric tube in place for simultaneous gastric decompression while being fed in the postpyloric intestine. Once scheduled for the PEG procedure, patients will be randomized to either the experimental NoFAST group or the control FAST group. The NoFAST group will undergo naso- or orogastrointestinal tube feeding until 1 hour before the scheduled PEG procedure if the stomach is receiving EN, or until procedural timeout if the post-pyloric intestine is receiving EN. At the time tube feeding is stopped for the procedure, stomach contents will be aspirated by an oro- or nasogastric tube. The procedure will be carried out per standard clinical practice. At completion of the procedure, tube feeding will be resumed at the preprocedure rate. The FAST group will have naso- or orogastrointestinal feeding held at least 8 hours prior to the procedure, then for 4 hours after the procedure. Tube feeding will be resumed and titrated at the appointed time per standard CRMH clinical protocol for initiating tube feeding. All other procedures including PEG placement and feeding procedure will be completed to the standard of care for both groups. The patients will be monitored for hours fasted and calories delivered before and after the procedure, beginning 24 hours before the procedure until 24 hours after the procedure. Complications potentially attributable to the delivery of enteral nutrition, including feeding intolerance, will be monitored for 24 hours before until 72 hours after the procedure. Clinical postoperative monitoring will continue per standard of care for a minimum of six weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Once scheduled for the PEG procedure, patients will be randomized to either the experimental NoFAST group or the control FAST group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No Fast group
The NoFAST group will undergo naso- or orogastrointestinal tube feeding until 1 hour before the scheduled PEG procedure if the stomach is receiving EN, or until procedural timeout if the post-pyloric intestine is receiving EN. At the time tube feeding is stopped for the procedure, stomach contents will be aspirated by the oro- or nasogastric tube already in place. The procedure will be carried out per standard clinical practice. At completion of the procedure, tube feeding will be resumed at the preprocedure rate.
Dietary Supplement: noFAST group
Truncated fasting prior to procedure, early feeding after procedure

No Intervention: control FAST group
The FAST group will have naso- or orogastrointestinal feeding held at least 8 hours prior to the procedure, then for 4 hours after the procedure. Tube feeding will be resumed and titrated at the appointed time per standard CRMH clinical protocol for initiating tube feeding. All other procedures including PEG placement and feeding procedure will be completed to the standard of care for both groups.



Primary Outcome Measures :
  1. Hours fasted [ Time Frame: 24 hours before to 24 hours after the procedure ]
    Number of hours patients are not receiving prescribed enteral nutrition volume


Secondary Outcome Measures :
  1. Complications [ Time Frame: 24 hours before to 72 hours after the procedure ]
    Rate of complications potentially attributable to delivery of enteral nutrition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects over 18 years of age
  • Negative pregnancy test for women participants of child-bearing age
  • Ventilated surgical and trauma patients with clinical indication for PEG tube placement

Exclusion Criteria:

  • Patients with abberant gastrointestinal anatomy
  • Patients with gastrointestinal motility disorders
  • Patients with feeding intolerance prior to PEG tube procedure
  • Pregnant women, children, or other vulnerable populations
  • Clinical contraindications for PEG tube placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110613


Contacts
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Contact: Katie Bower, MD 540-320-9139 klbower1@carilionclinic.org
Contact: Davit Shahmanyan, BS 818-405-2030 dshahmanyan@carilionclinic.org

Locations
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United States, Virginia
Carilion Roanoke Memorial Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Michelle Rothrock    540-985-8510    mlrothrock@carilionclinic.org   
Sponsors and Collaborators
Carilion Clinic
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Katie L Bower, MD Physician
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Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT04110613    
Other Study ID Numbers: 19-355
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Critical Illness
Wounds and Injuries
Nutrition Disorders
Disease Attributes
Pathologic Processes