Effect of not fasting prior to coronary angiography and/or percutaneous coronary intervention on the incidence of vomiting and aspiration during the procedure.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000713493

Acronym

Nil

Enrollment

29400

Registered

2016-05-30

Start date

2016-08-20

Completion date

2018-12-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine whether fasting and non-fasting prior to coronary angiography are associated with a similar, very low likelihood of vomiting and aspiration pneumonitis.

Interventions

This is a cluster randomised, stepped wedge, study. Up to 29,400 patients planned to be enrolled at up to 12 clinical sites in New Zealand. Procedural details will be recorded in the national ANZACSQI registry. Patients in the nonfasted arm (intervention) can have free fluids right up to the procedure and will be recommended to not eat within 2 hours of the procedure and will be supervised by nursing staff prior to the procedure.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing elective or semi-urgent coronary angiography and/ or percutaneous coronary intervention

Exclusion criteria

Treating physician choice Patients having acute/emergency procedures, such as primary or rescue PCI for STEMI, or angiography for out-of-hospital cardiac arrest

Outcome results