Preoperative FastingNCT01516775
Gastric pH in Intubated Children
A study testing clear fluid ingestion in people with Preoperative Fasting, run by Achim Schmitz at 1 site in Switzerland.
Trial summary
Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Preoperative Fasting
- What is being tested?
- clear fluid ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Sep 2012
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age > 1 / <= 16 years
- ASA class I or II
- elective surgery requiring general anaesthesia using tracheal intubation
Who cannot join
- disease or dysfunction of gastrointestinal tract
- chronic diseases or conditions not compatible with ASA class I or II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern
Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk
Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction
- Conditions
- Preoperative Fasting
- Being tested
- clear fluid ingestion
- Keywords
- preoperative care, preoperative period, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear fluid ingestionOther
drinking of clear fluid in preoperative period
| Study group | Role | What they receive |
|---|---|---|
| 1 hour fluid fasting | Experimental | allowed to drink until 1 hour before scheduled anaesthesia induction Receives: Other: clear fluid ingestion |
| 2 hours fluid fasting | Active comparator | allowed to drink until 2 hour before scheduled anaesthesia induction Receives: Other: clear fluid ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric pH
gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution
Measured: within 10 min after tracheal intubation
Secondary outcomes (5)
subjective feeling of hunger/thirst
subjective feeling of hunger/thirst given as rating scale from 1 to 4
Measured: within 10 minutes after arrival of patient in operating theatre
gastric aspirate volume
gastric aspirate volume is the amount of gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution
Measured: within 10 min after tracheal intubation
Postoperative Nausea and Vomiting (PONV) in recovery unit
Measured: recovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during recovery period
Rating Scale 1 - 5 by blinded nurse (5: severely agitated/emergency delir with subsequent drug therapy, 4: agitated/emergeny delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)
Measured: recovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during anaesthesia induction
Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
Measured: on the average within 20 minutes after arrival of patient in operating theatre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achim Schmitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Achim Schmitz, University Children's Hospital, Zurich
- Investigators
- Achim J Schmitz, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516775
- Sponsor's protocol ID
- KEK-ZH Nr. 2011-0034
- Status last verified
- Sep 2012
- First submitted
- 16 Jan 2012
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt AR, Buehler P, Seglias L, Stark T, Brotschi B, Renner T, Sabandal C, Klaghofer R, Weiss M, Schmitz A. Gastric pH and residual volume after 1 and 2 h fasting time for clear fluids in childrendagger. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13.
PubMed 25501720
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern
- ClinicalTrials.gov ID
- NCT01516775
- Acronym / sponsor ID
- KEK-ZH Nr. 2011-0034
- Conditions
- Preoperative Fasting
- Keywords
- preoperative care, preoperative period, fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Achim SchmitzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Jan 2012 (estimated)
- 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.
Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk
Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 hour fluid fasting | Experimental | Other: clear fluid ingestionallowed to drink until 1 hour before scheduled anaesthesia induction |
| 2 hours fluid fasting | Active comparator | Other: clear fluid ingestionallowed to drink until 2 hour before scheduled anaesthesia induction |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age > 1 / <= 16 years
- ASA class I or II
- elective surgery requiring general anaesthesia using tracheal intubation
Key exclusion criteria (2 listed)
- disease or dysfunction of gastrointestinal tract
- chronic diseases or conditions not compatible with ASA class I or II
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 |
|---|---|---|
| clear fluid ingestiondrinking of clear fluid in preoperative period | Other | 1 hour fluid fasting, 2 hours fluid fasting |
Primary outcome
gastric pH
Time frame: within 10 min after tracheal intubation
gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution
5 secondary outcomes
subjective feeling of hunger/thirst
Time frame: within 10 minutes after arrival of patient in operating theatre
gastric aspirate volume
Time frame: within 10 min after tracheal intubation
Postoperative Nausea and Vomiting (PONV) in recovery unit
Time frame: recovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during recovery period
Time frame: recovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during anaesthesia induction
Time frame: on the average within 20 minutes after arrival of patient in operating theatre
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 1 Oct 2012.
- Derived from this study: PubMed 25501720Schmidt AR, Buehler P, Seglias L, Stark T, Brotschi B, Renner T, Sabandal C, Klaghofer R, Weiss M, Schmitz A. Gastric pH and residual volume after 1 and 2 h fasting time for clear fluids in childrendagger. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13.
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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.
Achim J Schmitz, MD principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clear fluid ingestion in people with Preoperative Fasting, run by Achim Schmitz at 1 site in Switzerland.
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 2 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 1 Oct 2012. 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 Switzerland. 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 pH (time frame: within 10 min after tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516775, which also lists 1 linked publication.
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 1 Oct 2012.