FastingNCT05685446
Gastric Volume After Drinking 175 ml of Ice Water Prior to Gastroscopy in Healthy Adult Patients
A study testing Ice water in people with Fasting and Perioperative Pulmonary Aspiration, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting, Perioperative Pulmonary Aspiration
- What is being tested?
- Ice water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2020to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Emptying and Gastric Volume After Ingestion of 175 ml of Ice Water Prior to Elective Gastroscopy in Healthy Adults
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.
- Conditions
- Fasting, Perioperative Pulmonary Aspiration
- Being tested
- Ice water
- Keywords
- Gastroscopy, Gastric volume, Anaesthesia
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice waterOther
Also called Iced tap water
Ingestion of 175 ml iced tap water 15 minutes prior to elective gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| 175 ml ice water | Experimental | Ingestion of 175 ml ice water 15 minutes prior to gastroscopy Receives: Other: Ice water |
| Fasting | No intervention | Continued fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume
Aspired residual gastric fluid volume at start of gastroscopy
Measured: 15 minutes
Secondary outcomes (1)
Nausea and dyspepsia
Proportion of patients reporting nausea or dyspeptic symptoms prior to gastroscopy
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start3 Mar 2020
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Caroline Hornnes Pedersen, Regionshospital Nordjylland
- Investigators
- Kjeld Damgaard, MD, PhD, Study chair, Regional Hospital of Northern Denmark, Hjørring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685446
- Sponsor's protocol ID
- N-20190056
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying and Gastric Volume After Ingestion of 175 ml of Ice Water Prior to Elective Gastroscopy in Healthy Adults
- ClinicalTrials.gov ID
- NCT05685446
- Acronym / sponsor ID
- N-20190056
- Conditions
- Fasting, Perioperative Pulmonary Aspiration
- Keywords
- Gastroscopy, Gastric volume, Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 175 ml ice water | Experimental | Other: Ice waterIngestion of 175 ml ice water 15 minutes prior to gastroscopy |
| Fasting | No intervention | –Continued fasting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice waterAlso: Iced tap waterIngestion of 175 ml iced tap water 15 minutes prior to elective gastroscopy | Other | 175 ml ice water |
Primary outcome
Gastric residual volume
Time frame: 15 minutes
Aspired residual gastric fluid volume at start of gastroscopy
1 secondary outcome
Nausea and dyspepsia
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Damgaard, MD, PhD study chair
Regional Hospital of Northern Denmark, Hjørring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice water in people with Fasting and Perioperative Pulmonary Aspiration, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric residual volume (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.