Fasting or Non-fasting Before Cardiac Catheterization

NCT05133206 | Unknown DMC

• 1 other identifier: 303042
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures. Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory). Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.

Conditions

Fasting; Coronary Artery Disease; Procedural Complication; Coronary Angiography

Keywords

Fasting; Non-fasting; Cardiac catheterization

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.

  incidence of self-reported nausea measured on a binary scale (yes or no)

  Within 4 hours after the procedure.

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting.

  Incidence of vomiting assessed on binary scale (yes or no).

  Within 4 hours after the procedure.

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension.

  Pre-procedural hypotension (systolic blood pressure \<90 mmHg and /or diastolic blood pressure \< 60 mmHg as measured non-invasively by sphygmomanometer)

  Within 2 hours before the procedure.

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia.

  Incidence of hypoglycemia peri-procedure (blood sugar \< 3.6 mmol/l) as assessed by finger prick test.

  Within 2 hours before the procedure.

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation.

  Incidence of emergency tracheal intubation for respiratory failure

  During the procedure

• Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia.

  Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia.

  During the procedure

Secondary Outcomes (1)

• Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description

  Within 4 hours after the procedure

Study Arms (2)

Non-Fasting

EXPERIMENTAL

Oral fluids and food up to the time of the procedure.

Other: Advice on fasting before the procedure

Fasting

NO INTERVENTION

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

Interventions

Advice on fasting before the procedure OTHER

Patients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory.

Non-Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \>18 years undergoing elective coronary angiography or angioplasty procedures in the 2 months window from consent.

You may not qualify if:

• Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention.
• Emergency primary percutaneous coronary intervention.
• Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).

Sponsors & Collaborators

• Blackpool Victoria Hospital: lead

Study Sites (1)

Blackpool Victoria Hospital

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

Related Publications (6)

• Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015.

  PMID: 24438649 BACKGROUND

• Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.

  PMID: 14584013 BACKGROUND

• Kwon OK, Oh CW, Park H, Bang JS, Bae HJ, Han MK, Park SH, Han MH, Kang HS, Park SK, Whang G, Kim BC, Jin SC. Is fasting necessary for elective cerebral angiography? AJNR Am J Neuroradiol. 2011 May;32(5):908-10. doi: 10.3174/ajnr.A2408. Epub 2011 Mar 17.

  PMID: 21415144 BACKGROUND

• Hamid T, Aleem Q, Lau Y, Singh R, McDonald J, Macdonald JE, Sastry S, Arya S, Bainbridge A, Mudawi T, Balachandran K. Pre-procedural fasting for coronary interventions: is it time to change practice? Heart. 2014 Apr;100(8):658-61. doi: 10.1136/heartjnl-2013-305289. Epub 2014 Feb 12.

  PMID: 24522621 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, Kolansky DM. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255-276. doi: 10.1002/ccd.29744. Epub 2021 May 19.

  PMID: 33909349 BACKGROUND

Related Links

• Association of Anaesthetists of Great Britain and Ireland. AAGBI Safety Guideline 2010.

MeSH Terms

Conditions

Fasting; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hesham K Abdelaziz, MSc, PhD

  Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham K Abdelaziz, MSc, PhD

CONTACT

(+44) 01253957761; hesham.abdelaziz@nhs.net

Maciej Debski, MD, PhD

CONTACT

maciej.debski@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomisation will take place through a sealed envelope method controlled by the cardiac research team; patients will be allocated 1:1 to either fasting or non-fasting groups using random blocks of sizes 4, 6, and 8 to minimise imbalance in treatment groups and preserve blinding up until the point of randomisation. This information (whether fasting or not) will be relayed to the patient at the time of pre-procedure assessment. The people who collate the data (the cath lab team or research nurses) and the operator performing the procedure will be blinded to the patient allocation group and will not be involved in conducting the analysis. The treatment group will be relabelled before analysis (i.e. group A and group B for not-fasting and fasting, respectively).

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 24, 2021
• Study Start: March 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)