Gastric pH in Intubated Children - Part Two

NCT02603094 | Completed DMC

• 1 other identifier: KEK-ZH Nr. 2011-0034 Amend3
• Study Type: interventional
• Target: 180
• 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 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

Conditions

Preoperative 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 (7)

• gastric aspirate volume

  within 10 min after tracheal intubation

• subjective feeling of hunger/thirst

  baseline

• 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)

clear fluids until premedication

EXPERIMENTAL

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

Procedure: clear fluid ingestion

2 hours fluid fasting

ACTIVE COMPARATOR

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

Procedure: clear fluid ingestion

Interventions

clear fluid ingestion PROCEDURE

drinking of clear fluid in preoperative period

2 hours fluid fasting; clear fluids until premedication

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age \> 1 / \< 16 years ASA class l or ll 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 l or ll

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Childrens Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30115263 DERIVED

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

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

CH (1)