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NPO and Patient Satisfaction in the Cath Lab (FAST)

Primary Purpose

Patient Satisfaction, Dehydration, Physiological Effects Secondary to Dehydration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NPO past midnight
NPO
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Satisfaction focused on measuring Nil per os (NPO), TAVR, arrhythmia ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older,
  • patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
  • ability to provide written informed consent

Exclusion Criteria:

  • Age less than 18 years
  • emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
  • patients not alert and oriented to person, place, and date,
  • concurrent surgical procedures on the day of TAVR or arrhythmia ablation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Strict NPO

    Liberal NPO

    Arm Description

    NPO after midnight. No solids or liquids after midnight.

    No solids after midnight. Clear liquids up to 2 hours prior to surgery.

    Outcomes

    Primary Outcome Measures

    Patient Satisfaction: survey
    The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.

    Secondary Outcome Measures

    Exploratory Analyses
    An independent analysis of each individual component of the satisfaction survey will be performed. Each variable will be scored on a scale of 0-10. Variables: thirst, hunger, headache, nausea, lightheadedness, anxiety. Renal Function Vasopressor Requirement Post-operative nausea and vomiting Post-operative hospital length of stay

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    September 4, 2019
    Sponsor
    Stony Brook University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04079543
    Brief Title
    NPO and Patient Satisfaction in the Cath Lab
    Acronym
    FAST
    Official Title
    Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 9, 2019 (Anticipated)
    Primary Completion Date
    September 9, 2020 (Anticipated)
    Study Completion Date
    September 9, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stony Brook 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 purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.
    Detailed Description
    After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient Satisfaction, Dehydration, Physiological Effects Secondary to Dehydration
    Keywords
    Nil per os (NPO), TAVR, arrhythmia ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized (1:1) into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Strict NPO
    Arm Type
    Other
    Arm Description
    NPO after midnight. No solids or liquids after midnight.
    Arm Title
    Liberal NPO
    Arm Type
    Other
    Arm Description
    No solids after midnight. Clear liquids up to 2 hours prior to surgery.
    Intervention Type
    Other
    Intervention Name(s)
    NPO past midnight
    Intervention Description
    NPO after midnight (solids and liquids), except for a sip of water with medication.
    Intervention Type
    Other
    Intervention Name(s)
    NPO
    Intervention Description
    No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction: survey
    Description
    The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.
    Time Frame
    Up to 24 hours
    Secondary Outcome Measure Information:
    Title
    Exploratory Analyses
    Description
    An independent analysis of each individual component of the satisfaction survey will be performed. Each variable will be scored on a scale of 0-10. Variables: thirst, hunger, headache, nausea, lightheadedness, anxiety. Renal Function Vasopressor Requirement Post-operative nausea and vomiting Post-operative hospital length of stay
    Time Frame
    Through the end of hospitalization, usually 2 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older, patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital ability to provide written informed consent Exclusion Criteria: Age less than 18 years emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis, patients not alert and oriented to person, place, and date, concurrent surgical procedures on the day of TAVR or arrhythmia ablation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Derek Atkinson, MD
    Phone
    631-748-9310
    Email
    derek.atkinson@stonybrookmedicine.edu

    12. IPD Sharing Statement

    Learn more about this trial

    NPO and Patient Satisfaction in the Cath Lab

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