NCT05685446

Brief Summary

Recommendation for fluid fasting is two hours prior to anaesthesia, however, less may be acceptable. The current study compares ingestion of 175 ml ice water prior to elective gastroscopy vs. standard fasting on gastric residual volume.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

January 5, 2023

Last Update Submit

January 5, 2023

Conditions

FastingPerioperative Pulmonary Aspiration

Keywords

GastroscopyGastric volumeAnaesthesia

Outcome Measures

Primary Outcomes (1)

  • Gastric residual volume

    Aspired residual gastric fluid volume at start of gastroscopy

    15 minutes

Secondary Outcomes (1)

  • Nausea and dyspepsia

    15 minutes

Study Arms (2)

175 ml ice water

EXPERIMENTAL

Ingestion of 175 ml ice water 15 minutes prior to gastroscopy

Other: Ice water

Fasting

NO INTERVENTION

Continued fasting

Interventions

Ice waterOTHER

Ingestion of 175 ml iced tap water 15 minutes prior to elective gastroscopy

Also known as: Iced tap water
175 ml ice water

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective gastroscopy in a medical outpatient clinic
  • American Society of Anesthesiologists physical status classification system category (ASA score) I or II
  • Age 18 years or above

You may not qualify if:

  • Any increased risk of aspiration, eg. dysphagia, previous aspiration, non-fasting status, or known alcohol abuse
  • Suspected delayed gastric emptying, eg. regular opioid use within three days
  • Enteral pre-medication required
  • Any structural gastric or esophageal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaestesia

Hjørring, North Denmark, 9800, Denmark

Location

MeSH Terms

Conditions

Fasting

Interventions

major intrinsic protein, plant

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Kjeld Damgaard, MD, PhD

    Regional Hospital of Northern Denmark, Hjørring

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

March 3, 2020

Primary Completion

June 17, 2021

Study Completion

June 17, 2021

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)