Gastric pH in Intubated Children - Part Two

Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei

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

Study Overview

• Status: Completed
• Conditions: Preoperative Fasting
• Intervention / Treatment: Procedure: clear fluid ingestion

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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 clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours.	Procedure: 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	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
gastric aspirate volume	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		recovery period, on the average within 90 minutes after end of anaesthesia
subjective feeling of hunger/thirst	subjective feeling of hunger/thirst given as "yes" or "no" answer	baseline
Behaviour during recovery period	Rating Scale1-5 by blinded nurse (5: severely agitated/emergence delir with subsequent drug therapy, 4: agitated/emergence 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	Rating scale1-5 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
Nurse's Impression of patient's satisfactory	subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4	baseline
blood Ketone measurement	measurement of blood Ketone with a portable poc Ketone measurement device	intraoperative

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Achim J Schmitz, MD, University Children's Hospital, Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: KEK-ZH Nr. 2011-0034 Amend3