Gastric pH in Intubated Children - Part Two

Not Applicable

Completed

• Conditions: Preoperative Fasting
• Interventions: Procedure: clear fluid ingestion

• Registration Number: NCT02603094
• Lead Sponsor: University Children's Hospital, Zurich

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2015-12
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clear fluids until premedication	clear fluid ingestion	allowed to drink until premedication, aprox 30 minutes before anaesthesia induction. Fasting for solids and non-clear fluids is six hours.
2 hours fluid fasting	clear fluid ingestion	allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours.

Primary Outcome Measures

Name	Time	Method
gastric pH	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

Secondary Outcome Measures

Name	Time	Method
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	baseline	subjective feeling of hunger/thirst given as "yes" or "no" answer
Behaviour during recovery period	recovery period, on the average within 90 minutes after end of anaesthesia	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)
Nurse's Impression of patient's satisfactory	baseline	subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4
Behaviour during anaesthesia induction	on the average within 20 minutes after arrival of patient in operating theatre	Rating scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
gastric aspirate volume	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
blood Ketone measurement	intraoperative	measurement of blood Ketone with a portable poc Ketone measurement device

Trial Locations

Locations (1)

University Childrens Hospital; 🇨🇭 Zurich, Switzerland