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CompletedNCT05685446Updated Jan 17, 2023

Gastric Volume After Drinking 175 ml of Ice Water Prior to Gastroscopy in Healthy Adult Patients

An interventional study of Ice water in Fasting and Perioperative Pulmonary Aspiration, sponsored by Regionshospital Nordjylland. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Mar 2020, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Recommendations regarding fasting requirements prior to general anaesthesia is two hours for fluids. Recent research indicates that reduced fluid fasting time may be acceptable. The current study aimed to compare ingestion of 175 ml ice water 15 minutes prior to procedure compared to standardized fasting regimen on residual gastric volumes in patients receiving elective gastroscopy, as these volumes may have implications for fasting requirements.

02

Conditions studied

  • Fasting
  • Perioperative Pulmonary Aspiration

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Keywords

  • Gastroscopy
  • Gastric volume
  • Anaesthesia
03

In context

Fasting

392 studies on the registry are indexed under Fasting; 63 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 311 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    175 ml ice water

    Ingestion of 175 ml ice water 15 minutes prior to gastroscopy

    Other: Ice water

  • No intervention
    Fasting

    Continued fasting

Interventions

  • OtherIce water

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

    Also known as: Iced tap water

06

What researchers measure

Primary outcomes

  1. Gastric residual volume

    Aspired residual gastric fluid volume at start of gastroscopy

    Time frame: 15 minutes

Secondary outcomes

  1. Nausea and dyspepsia

    Proportion of patients reporting nausea or dyspeptic symptoms prior to gastroscopy

    Time frame: 15 minutes

07

Study locations

1 site
  • Department of Anaestesia
    Hjørring, North Denmark 9800, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Jun 2021, 15 months.

Of 144 non-industry interventional studies with no phase under Fasting, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's 15 months is below that.

Counting every sponsor, half of 149 studies reached it within 18 months; a quarter within 6 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2023
First posted
Jan 17, 2023
StartActual
Mar 3, 2020
Primary completionActual
Jun 17, 2021
CompletionActual
Jun 17, 2021
Last update
Jan 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05685446
Lead sponsor
Regionshospital Nordjylland
Responsible party
Caroline Hornnes Pedersen (MD, Regionshospital Nordjylland) — Principal investigator
First posted
Jan 17, 2023
Start date
Mar 3, 2020
Primary completion
Jun 17, 2021
Completion
Jun 17, 2021
Last update
Jan 17, 2023

Study contacts

Kjeld Damgaard, MD, PhD
study chair · Regional Hospital of Northern Denmark, Hjørring

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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