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Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

Primary Purpose

Ventilator Associated Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eliminating gastric residual volume monitoring
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults (aged≥18 years) Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours. Starting enteral nutrition via a nasogastric tube within 36 hours after intubation. Exclusion Criteria: Abdominal surgery within the past month. History of esophageal, duodenal, pancreatic, or gastric surgery. Bleeding from the esophagus, stomach, or bowel. Enteral nutrition via a jejunostomy or gastrostomy. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    intervention groups

    control group

    Arm Description

    Patients in the intervention group will not be monitored for GRV (no GRV monitoring) and will be evaluated for the presence of feeding intolerance indicators such as vomiting, regurgitation, and abdominal distention.

    Patients in the control group will be subjected to GRV monitoring (with GRV monitoring).

    Outcomes

    Primary Outcome Measures

    eliminating gastric residual volume monitoring on ventilator associated events
    use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021

    Secondary Outcome Measures

    eliminating gastric residual volume monitoring on nutritional adequacy
    evaluation daily caloric requirement by body mass index that calculated using the equation (Weight in kg /height in cm) 2
    eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators
    evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Damanhour University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06059040
    Brief Title
    Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events
    Official Title
    Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Damanhour University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV monitoring on feeding intolerance in patients receiving enteral feeding.
    Detailed Description
    Early enteral nutrition (EN) is consistently recommended as first line nutrition therapy in critically ill patients since it favorably alters outcome, providing both nutrition and non-nutrition benefits. However, critically ill patients receiving mechanical ventilation (MV) are at risk for regurgitation, pulmonary aspiration, and eventually ventilator-associated pneumonia (VAP). EN may increase these risks when gastrointestinal (GI) dysfunction is present. Gastric residual volume (GRV) is considered a surrogate parameter of GI dysfunction during the progression of enteral feeding in the early phase of critical illness and beyond. About 62% of critically ill patients receive enteral nutrition (EN) and in patients on MV, enteral feeding was connected to a threefold increase in the development of VAP. A new surveillance definition of ventilator-associated events (VAE) was introduced by the National Healthcare Safety Network (NHSN) in 2013 to identify patients who develop complications of MV. It outlines the various events in a step-by-step fashion, beginning with ventilator-associated complications (VAC), moving on to infectious complications (IVAC), and finally VAP. According to the NHSN, VAEs occur within 9% to 40% of mechanically ventilated patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A parallel randomized controlled design will be used in this study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention groups
    Arm Type
    Active Comparator
    Arm Description
    Patients in the intervention group will not be monitored for GRV (no GRV monitoring) and will be evaluated for the presence of feeding intolerance indicators such as vomiting, regurgitation, and abdominal distention.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients in the control group will be subjected to GRV monitoring (with GRV monitoring).
    Intervention Type
    Procedure
    Intervention Name(s)
    eliminating gastric residual volume monitoring
    Intervention Description
    eliminating gastric residual volume monitoring from routine care
    Primary Outcome Measure Information:
    Title
    eliminating gastric residual volume monitoring on ventilator associated events
    Description
    use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    eliminating gastric residual volume monitoring on nutritional adequacy
    Description
    evaluation daily caloric requirement by body mass index that calculated using the equation (Weight in kg /height in cm) 2
    Time Frame
    3 month
    Title
    eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators
    Description
    evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults (aged≥18 years) Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours. Starting enteral nutrition via a nasogastric tube within 36 hours after intubation. Exclusion Criteria: Abdominal surgery within the past month. History of esophageal, duodenal, pancreatic, or gastric surgery. Bleeding from the esophagus, stomach, or bowel. Enteral nutrition via a jejunostomy or gastrostomy. Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enas Abdel sadek, Demonstrator
    Phone
    01093168809
    Email
    Enas_shoeab@nur.edu.dam.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Sahar Younes, Assistant Professor
    Phone
    01005551564
    Email
    sahar.younes.ramadan@nur.dmu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34596901
    Citation
    Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2.
    Results Reference
    background
    PubMed Identifier
    23321763
    Citation
    Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.
    Results Reference
    background
    PubMed Identifier
    30677592
    Citation
    Wang Z, Ding W, Fang Q, Zhang L, Liu X, Tang Z. Effects of not monitoring gastric residual volume in intensive care patients: A meta-analysis. Int J Nurs Stud. 2019 Mar;91:86-93. doi: 10.1016/j.ijnurstu.2018.11.005. Epub 2019 Jan 3.
    Results Reference
    background

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    Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

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