Gastric pH in Intubated Children

NCT01516775 | Completed

• 1 other identifier: KEK-ZH Nr. 2011-0034
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

preoperative care; preoperative period; fasting

Outcome Measures

Primary Outcomes (1)

• 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

  within 10 min after tracheal intubation

Secondary Outcomes (5)

• subjective feeling of hunger/thirst

  within 10 minutes after arrival of patient in operating theatre

• gastric aspirate volume

  within 10 min after tracheal intubation

• Postoperative Nausea and Vomiting (PONV) in recovery unit

  recovery period, on the average within 90 minutes after end of anaesthesia

• Behaviour during recovery period

  recovery period, on the average within 90 minutes after end of anaesthesia

• Behaviour during anaesthesia induction

  on the average within 20 minutes after arrival of patient in operating theatre

Study Arms (2)

1 hour fluid fasting

EXPERIMENTAL

allowed to drink until 1 hour before scheduled anaesthesia induction

Other: clear fluid ingestion

2 hours fluid fasting

ACTIVE COMPARATOR

allowed to drink until 2 hour before scheduled anaesthesia induction

Other: clear fluid ingestion

Interventions

clear fluid ingestion OTHER

drinking of clear fluid in preoperative period

1 hour fluid fasting; 2 hours fluid fasting

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• disease or dysfunction of gastrointestinal tract
• chronic diseases or conditions not compatible with ASA class I or II

Sponsors & Collaborators

• Achim Schmitz: lead

Study Sites (1)

University Children's Hospital

Zurich, 4153, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25501720 DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Achim J Schmitz, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator, Consultant ("Leitender Arzt Anästhesieabteilung, Leiter Weisse Zone")

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

CH (1)