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Gastric pH in Intubated Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achim Schmitz, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01516775
First received: January 16, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Preoperative Fasting
 Other: clear fluid ingestion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • gastric pH [ Time Frame: within 10 min after tracheal intubation ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • subjective feeling of hunger/thirst [ Time Frame: within 10 minutes after arrival of patient in operating theatre ] [ Designated as safety issue: No ]
    subjective feeling of hunger/thirst given as rating scale from 1 to 4

  • gastric aspirate volume [ Time Frame: within 10 min after tracheal intubation ] [ Designated as safety issue: No ]
    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

  • Postoperative Nausea and Vomiting (PONV) in recovery unit [ Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia ] [ Designated as safety issue: No ]
  • Behaviour during recovery period [ Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia ] [ Designated as safety issue: No ]
    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)

  • Behaviour during anaesthesia induction [ Time Frame: on the average within 20 minutes after arrival of patient in operating theatre ] [ Designated as safety issue: No ]
    Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting


Enrollment: 150
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516775

Locations
Switzerland
University Children's Hospital
Zurich, Switzerland, 4153
Sponsors and Collaborators
Achim Schmitz
Investigators
Principal Investigator: Achim J Schmitz, MD University Children's Hospital Zurich, Switzerland
  More Information

No publications provided

Responsible Party: Achim Schmitz, Principle Investigator, Consultant ("Leitender Arzt Anästhesieabteilung, Leiter Weisse Zone"), University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01516775     History of Changes
Other Study ID Numbers: KEK-ZH Nr. 2011-0034
Study First Received: January 16, 2012
Last Updated: September 28, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
preoperative care
preoperative period
fasting

ClinicalTrials.gov processed this record on May 22, 2013