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Preoperative Fasting for Ambulatory Cataract Surgery: The PRACTICE Study (PRACTICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828500
Recruitment Status : Unknown
Verified January 2019 by Sherif El-Defrawy, University of Toronto.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif El-Defrawy, University of Toronto

Brief Summary:

The current standard for cataract surgery is phacoemulsification with intraocular lens (IOL) implantation. In this procedure, topical anesthesia has become favoured over local anesthetic blocks due to potential serious complications resulting from retrobulbar or peribulbar anesthesia. Routinely, intravenous sedation is used to supplement the topical anesthesia. If patients are not fasted, there is the potential to reduce preoperative discomfort and anxiety, ultimately improving the satisfaction with the care received. An additional benefit is that liberal fasting policies allow for flexibility in the scheduling of cases, particularly for urgent or semi-urgent situations. Clinical practice guidelines for cataract surgery published by the Canadian Ophthalmological Society (COS) recommend that fasting is unnecessary if only topical anesthesia is used without intravenous (IV) opiates or sedation. In general, these suggestions are in agreement with guidelines from the United Kingdom's Royal College of Ophthalmologists, who note that "it is unnecessary to fast patients for local anesthetic cataract surgery." According to the CAS practice guidelines, the same fasting restrictions are applied when IV sedation or anesthesia with peripheral nerve blocks (e.g. retrobulbar or peribulbar blocks) are administered. At our centre at the Kensington Eye Institute (KEI) in Toronto, Canada, almost all cataract patients receive fentanyl and midazolam, with propofol given only in rare circumstances with close observation.

This research project at the Kensington Eye Institute will consist of two phases, namely a prospective, consecutive observational analysis and a prospective time-interrupted study. In the first phase, an observational analysis will be conducted in which consecutive cataract surgery patients will be surveyed with a validated questionnaire to assess their satisfaction. Inclusion criteria will include any cataract patient scheduled for surgery who is willing and able to participate in the study, with fully informed consent provided.

Previously published literature has evaluated the use of a patient satisfaction questionnaire regarding preoperative fasting, which includes items on hunger, thirst, hoarseness of voice, difficulty breathing, pain, agitation, anxiety, nausea, vomiting, shivering and problems with concentration. A Research Assistant will complete the questionnaire with all patients preoperatively at KEI, as well as a baseline demographic checklist that will include the patient's age, gender, laterality, surgeon, length of time fasted for solids and clear liquids, as well as the type and amount of solids and liquids. Secondary endpoints will be collected postoperatively and will include the incidence of aspiration, nausea and vomiting, as well as the rate of cancellations of surgeries directly related to issues with fasting guidelines. The first phase of the study will be used to conduct an appropriate sample size calculation, which will ensure that our second phase is not underpowered for the primary efficacy endpoint.

In the second phase, a time-interrupted prospective study will be established with the following two arms: (1) experimental arm: patients will be encouraged by the Research Assistant to drink clear fluids right up to the 2 hour limit as specified in the latest ASA and CAS guidelines, with no intervention applied for solids, and (2): control arm: standard of care without any encouragement to drink clear fluids up to the 2 hour limit. Patients will be assigned to groups based on month, so that the first month of study execution will enroll all patients into the experimental arm, the second month will enroll only into the control arm, and that subsequent months will alternate enrollment in a similar method.

Given the design, the study will be in accordance with the latest ASA and CAS preoperative fasting guidelines, and will not involve any use of financial or other methods of coercion to incentivize patients that are randomly assigned to the experimental arm. The encouragement process will only involve the Research Assistant asking and encouraging the patient to drink a standardized quantity of clear fluid (up to 400mL of water, coffee, tea, apple or cranberry juice and maximum of 2 teaspoons of sugar) up to the ASA and CAS mandated guideline of 2 hours preoperatively, with the patient making the final determination of whether to comply. Following the encouragement process, a demographics and satisfaction questionnaire will be administered to each patient preoperatively, as well as another satisfaction questionnaire administered following the surgery. Baseline demographics, primary and secondary endpoints will remain consistent with the first phase.


Condition or disease Intervention/treatment Phase
Cataract Extraction Fasting Aspiration Pneumonitis Behavioral: Assistant-encouraged fasting up to ASA/CAS guideline limits Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Not masked
Primary Purpose: Health Services Research
Official Title: Preoperative Fasting for Ambulatory Cataract Surgery: A Time-Interrupted Prospective Study
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Experimental Arm
encouraged by Research Assistant to drink clear fluids up to 2 hour limit. Arm 2 - standard of care
Behavioral: Assistant-encouraged fasting up to ASA/CAS guideline limits
Research Assistant encourages patient to drink clear fluids up to 2 hour limit before surgery, in accordance with the latest ASA and CAS guidelines.

No Intervention: Control Arm



Primary Outcome Measures :
  1. Demographic baseline parameters [ Time Frame: Immediately post-operatively ]
    Patient number, age, gender, surgery on left or right eye, surgeon, fasting time - solids (hours), fasting time - clear liquids (hours), solid foods eaten in last 24 hours, liquids drank in last 24 hours

  2. Satisfaction Questionnaire [ Time Frame: Immediately post-operatively ]

    Hunger, thirst, voice hoarseness, difficulty breathing, pain, agitation, anxiety, nausea, vomiting, shivering, difficulty in concentration

    Scale name: patient satisfaction with preoperative fasting questionnaire

    For this scale, the following choices will be provided for each item: strongly agree, agree, neutral, disagree, strongly disagree.

    Strongly agree and agree options represent a worse outcome. Strongly disagree and disagree options represent a better outcome.

    The scores from individual items will be averaged to yield a total score.



Secondary Outcome Measures :
  1. Regarding patient satisfaction survey [ Time Frame: Immediately post-operatively ]
    The proportion of participants that believe the survey is effective, clear, relevant, simple and consistent in measuring distress and burden of preoperative fasting. The number of participants that suggest further questions to add to the existing survey.


Other Outcome Measures:
  1. Rates of postoperative aspiration [ Time Frame: Immediately post-operatively ]
    The proportion of patients in sample sustaining aspiration postoperatively.

  2. Rates of cancellation of surgery due to preoperative fasting requirement violation [ Time Frame: Immediately post-operatively ]
    The proportion of cataract surgery patients at the surgical centre in the study timeframe needing to have surgery cancelled due to preoperative fasting requirement violation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any cataract patient scheduled for surgery at the Kensington Eye Institute who is willing and able to participate in the study, with fully informed consent provided.

Exclusion Criteria:

-


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): NCT03828500


Contacts
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Contact: Mano Chandrakumar, MSc 4169787931 mchandrakumar@KensingtonHealth.org

Locations
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Canada, Ontario
Kensington Eye Institute
Toronto, Ontario, Canada, M5T 3A9
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Sherif El-Defrawy, MD, PhD, FRCSC Kensington Eye Institute
Publications:
Royal College of Ophthalmologists. Cataract Surgery Guidelines. London, UK: Royal College of Ophthalmologists, 2004.

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Responsible Party: Sherif El-Defrawy, Chair and Professor of Department of Ophthalmology and Vision Sciences, University of Toronto
ClinicalTrials.gov Identifier: NCT03828500    
Other Study ID Numbers: PRACTICE_2019_001
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sherif El-Defrawy, University of Toronto:
Cataract
Cataract Extraction
Fasting
Preoperative Period
Interrupted Time Series Analysis
Guideline
Patient Care
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Cataract
Lens Diseases
Eye Diseases
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases