Duration of Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial

NCT04527757 | Completed DMC

• 1 other identifier: KDAR FN Brno 2020/09
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous anaesthesia induction is nowadays considered as gold standard, mainly because of the possibility of the rapid therapeutic intervention while having secured i.v. line. In the paediatric patients, apart from intravenous induction, it is also possible to use in the specific situations inhalation anaesthesia induction with sevoflurane (in the mixture with O2 + air, or O2 + N2O) and secure the i.v. line afterwards in the inhalation anaesthesia. This method is in the paediatric population currently preferred, mainly because of possible fear of the painful venipuncture. Inhalation anaesthesia induction is possible only in patients without the risk of aspiration/regurgitation of stomach content and in patients without predicted difficult airway. Even if sedative premedication is used, during the inhalation induction excitation stage of the general anaesthesia variably appears, during which hemodynamic sympathoadrenal response and involuntary limbs movement might occur. When deepening inhalation anaesthesia, progression to surgical stage and automatic breathing onset appears. This subsequently facilitates to secure the venous access, without which is is not possible to secure the airway (in exception of the emergency situations - resuscitation).

Conditions

Anaesthesia Induction

Keywords

Anaesthesia; Paediatric; Inhalation; Intravenous

Outcome Measures

Primary Outcomes (1)

• duration of anaesthesia induction

  The average duration of inhalation and intravenous anaesthesia induction will be measured, defined as the time since the beginning of monitoring of the vital functions (ECG, pulse oximetry, non-invasive blood pressure measurement) until the first ETCO2 wave.

  Intraoperatively

Secondary Outcomes (6)

• The number of attempts needed to secure i.v. line

  Intraoperatively

• success rate of securing the i.v. line while using EMLA patch and/or Buzzy

  Intraoperatively

• Airway management

  Intraoperatively

• incidence of adverse events

  Intraoperatively

• Type of premedication

  Intraoperatively

Study Arms (2)

Paediatric patients with inhalation induction

The measurement will begin after the patient's arrival at the operating theatre, after the control of the documentation and beginning of the vital signs monitoring. The measurement will be terminated at the occurence of the first ETCO2 wave, after securing the airway with laryngeal mask or orotracheal intubation. For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).

Procedure: Inhalation induction

Paediatric patients with intravenous induction

The measurement will begin after the patient's arrival at the operating theatre, after the control of the documentation and beginning of the vital signs monitoring. The measurement will be terminated at the occurence of the first ETCO2 wave, after securing the airway with laryngeal mask or orotracheal intubation. For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O). For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).

Procedure: Intravenous induction

Interventions

Inhalation induction PROCEDURE

For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).

Also known as: Anaesthesia inhalation induction

Paediatric patients with inhalation induction

Intravenous induction PROCEDURE

For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).

Also known as: Anaesthesia intravenous induction

Paediatric patients with intravenous induction

Eligibility Criteria

• Age: 28 Days - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.

You may qualify if:

• paediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.

You may not qualify if:

• Patients in the age from 0 to 1 month
• patients with predicted difficult airway
• emergency/urgent surgeries
• patients at the risk of regurgitation/aspiration of the stomach content
• procedures in which the airway will not be secured with laryngeal mask or orotracheal intubation
• cases were the time of induction can not be measured
• patients with intravenous line in situ

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Petr Štourač, prof. MD., Ph.D.

  Faculty of medicince Masaryk University and University Hospital Brno

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.MD,Ph.D.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 27, 2020
• Study Start: October 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CZ (1)