Gastric pH in Intubated Children

September 28, 2012 updated by: Achim Schmitz

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 4153
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 hour fluid fasting
allowed to drink until 1 hour before scheduled anaesthesia induction
Other: clear fluid ingestion
drinking of clear fluid in preoperative period
Active Comparator: 2 hours fluid fasting
allowed to drink until 2 hour before scheduled anaesthesia induction
Other: clear fluid ingestion
drinking of clear fluid in preoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 10 min after tracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective feeling of hunger/thirst
Time Frame: within 10 minutes after arrival of patient in operating theatre
subjective feeling of hunger/thirst given as rating scale from 1 to 4
within 10 minutes after arrival of patient in operating theatre
gastric aspirate volume
Time Frame: within 10 min after tracheal intubation
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
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
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
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)
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
Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
on the average within 20 minutes after arrival of patient in operating theatre

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Achim Schmitz

Investigators

  • Principal Investigator: Achim J Schmitz, MD, University Children's hospital, Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KEK-ZH Nr. 2011-0034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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