Gastric pH in Intubated Children - Part Two

NCT ID: NCT02603094

Last Updated: 2016-09-19

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-08-31

Brief Summary

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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 general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk

Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction

Detailed Description

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Conditions

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Preoperative Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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clear fluids until premedication

allowed to drink until premedication, aprox 30 minutes before anaesthesia induction. Fasting for solids and non-clear fluids is six hours.

Group Type EXPERIMENTAL

clear fluid ingestion

Intervention Type PROCEDURE

drinking of clear fluid in preoperative period

2 hours fluid fasting

allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours.

Group Type ACTIVE_COMPARATOR

clear fluid ingestion

Intervention Type PROCEDURE

drinking of clear fluid in preoperative period

Interventions

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clear fluid ingestion

drinking of clear fluid in preoperative period

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

age \> 1 / \< 16 years ASA class l or ll 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 l or ll
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Achim J Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

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University Childrens Hospital

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Schmidt AR, Buehler KP, Both C, Wiener R, Klaghofer R, Hersberger M, Weiss M, Schmitz A. Liberal fluid fasting: impact on gastric pH and residual volume in healthy children undergoing general anaesthesia for elective surgery. Br J Anaesth. 2018 Sep;121(3):647-655. doi: 10.1016/j.bja.2018.02.065. Epub 2018 May 3.

Reference Type DERIVED
PMID: 30115263 (View on PubMed)

Other Identifiers

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KEK-ZH Nr. 2011-0034 Amend3

Identifier Type: -

Identifier Source: org_study_id

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