Gastric pH in Intubated Children - Part Two

Preoperative Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603094
• Other study ID #: KEK-ZH Nr. 2011-0034 Amend3
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: September 16, 2016
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Preoperative Fasting

Intervention

Procedure:
• clear fluid ingestion
drinking of clear fluid in preoperative period

Locations

Country	Name	City	State
Switzerland	University Childrens Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	subjective feeling of hunger/thirst	subjective feeling of hunger/thirst given as "yes" or "no" answer	baseline	No
Secondary	Postoperative Nausea and Vomiting (PONV) in recovery unit		recovery period, on the average within 90 minutes after end of anaesthesia	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	blood Ketone measurement	measurement of blood Ketone with a portable poc Ketone measurement device	intraoperative	No