Gastric pH in Intubated Children

NCT ID: NCT01516775

Last Updated: 2012-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preoperative Fasting

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

preoperative care preoperative period fasting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 hour fluid fasting

allowed to drink until 1 hour before scheduled anaesthesia induction

Group Type EXPERIMENTAL

clear fluid ingestion

Intervention Type OTHER

drinking of clear fluid in preoperative period

2 hours fluid fasting

allowed to drink until 2 hour before scheduled anaesthesia induction

Group Type ACTIVE_COMPARATOR

clear fluid ingestion

Intervention Type OTHER

drinking of clear fluid in preoperative period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

clear fluid ingestion

drinking of clear fluid in preoperative period

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 1 / \<= 16 years
* ASA class I or II
* elective surgery requiring general anaesthesia using tracheal intubation

Exclusion Criteria

* disease or dysfunction of gastrointestinal tract
* chronic diseases or conditions not compatible with ASA class I or II
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Achim Schmitz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Achim Schmitz

Principle Investigator, Consultant ("Leitender Arzt Anästhesieabteilung, Leiter Weisse Zone")

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Achim J Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Children's Hospital

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25501720 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK-ZH Nr. 2011-0034

Identifier Type: -

Identifier Source: org_study_id