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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03555500
Other study ID # 215149
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2017
Est. completion date March 10, 2019

Study information

Verified date June 2018
Source Blackpool Victoria Hospital
Contact Hesham Abdelaziz, Ph.D
Phone +44(0) 1253957790
Email hesham.abdelaziz@bfwhospitals.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current practice of fasting before cardiac catheterization is not based on any studies. If the procedure is to be delayed ( which is common due to busy catheterization lab), this could result in patient's dis-satisfaction and hypoglycemia. Occasionally, cancellation occur because patients are found to be non fasting ( not following the current protocol). The old data of fasting was extrapolated from procedure done under general anesthesia. Now days, cardiac catheterization is always done under local anesthesia and mild sedation. As a matter of fact, emergency cardiac catheterization done for heart attack patients carries more risk than elective one , and are still done without fasting with no reported complication rate like lung aspiration . The highest level of evidence to change the current practice comes from randomized control study. This study has been designed to challenge the current practice. The patients will be divided into 2 groups:

- Fasting group (current practice): Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure.

- Non Fasting Group: clear fluids and food and up to the time of the procedure

The investigators' aim is to show that there is no difference with regards to potential complications between fasting (current practice) and non fasting (new practice) groups of patients with less incidence of hypoglycemia and hypotension in non fasting group. In addition, The investigators believe that patient satisfaction will be improved if patients are allowed to eat freely before the procedure and the catheter lab working ability will be maximized as the list can be filled promptly with patient on the waiting list (as fasting is no longer required) if a previously booked patient has to be cancelled in the last minute improving patient experience along with the associated financial benefits.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non fasting
Non fasting group is allowed for clear fluids and food up to the time of the procedure.

Locations

Country Name City State
United Kingdom Blackpool Victoria Hospital Blackpool Lancashire

Sponsors (1)

Lead Sponsor Collaborator
Blackpool Victoria Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration The incidence of any of nausea, vomiting, abdominal pain aspiration or emergency intubation during the procedure and up to 8 hours will be recorded. 8 hours
Secondary Incidence of hypoglycaemia Drop of Blood sugar < 3.6 mmol/l as assessed by finger prick test before the procedure. 1 hour
Secondary Incidence of hypotension Drop of SBP<90 mmHg and /or DBP<60 mmHg as measured by manual sphygmomanometer before the procedure. 1 hour
Secondary Patient satisfaction A questionnaire given to the patient after the procedure to assess their experience , symptoms and overall satisfaction with regard to the procedure. The questionnaire include a preset of yes/no question including feeling hungry, thirsty or lethargic before the procedure, feeling headache, nausea or vomited during or up to 1 hour after the procedure. then a final overall satisfaction score about the procedure today from 1- 5, with 1 being not satisfied and 5 being extremely satisfied. 1 hour
Secondary chest infection All patients will be contacted or reviewed in clinic to assess for chest infection At 30 days
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