NCT02810288

Brief Summary

Respiratory adverse events continue to be the leading reason for perioperative critical events in children. It is crucial for the anaesthesiologist to anticipate, recognize and treat these respiratory adverse events. Respiratory adverse events are one of the major causes of morbidity and mortality during paediatric anaesthesia. To avoid trouble, one must be prepared for trouble: if a difficult airway is very likely, anaesthesia should be administered by experienced anaesthesiologists and should only be performed in a protected well-equipped area where the personnel adequately trained. This survey focuses on assessment and management of paediatric airway and highlights the unique challenges encountered in children.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 14, 2016

Last Update Submit

June 22, 2016

Conditions

Keywords

Airway anatomydifficult intubationcongenital syndromes

Outcome Measures

Primary Outcomes (1)

  • Proportion of anaesthesiologist with paediatric experience using intravenous induction compared to those without paediatric experience.

    The primary objective will be to compare anaesthesiologists with and without paediatric experience in terms of proportion of anaesthesiologists adopting "standard" practice.

    A time of survey; generally less than 20 minutes

Secondary Outcomes (4)

  • Proportion of anaesthesiologist with paediatric experience measuring cuff pressure with pressure manometer compared to those without paediatric experience.

    A time of survey; generally less than 20 minutes

  • Proportion of participants correctly identifying predictability of difficult airway in children.

    A time of survey; generally less than 20 minutes

  • Proportion of participants correctly answering questions about the use of (modified) rapid sequence induction in the paediatric population.

    A time of survey; generally less than 20 minutes

  • Proportion of anaesthesiologist correctly identifying national organisations difficult airway recommendations.

    A time of survey; generally less than 20 minutes

Study Arms (2)

Expert

Anaesthesiologist with large paediatric daily practice. All participant voluntarily response all items in the questionnaire database.

Behavioral: Voluntarily response all items in the questionnaire.

Non-experts

Anaesthesiologist with little paediatric daily practice. All participant voluntarily response all items in the questionnaire database.

Behavioral: Voluntarily response all items in the questionnaire.

Interventions

The study type is a cross-sectional study, by means of electronic self-administered survey as online questionnaire sent by e-mail. The questionnaire for the survey was developed with reference to previously published guidelines on the design of questionnaire surveys. The content validity of the questionnaire was verified by review of clinicians not participating into the project and by a statistician.

ExpertNon-experts

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers among the anaesthesiological community of 5 different European countries. All participant voluntarily response all items in the questionnaire database. A representative anaesthesiologist for each of the target Countries will be asked to participate and to invite at least one other hospital. All anaesthesiologists within each selected hospital will be asked to participate in the survey.

You may qualify if:

  • Anaesthesiologists currently working in the operating rooms.

You may not qualify if:

  • unwilling to join the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (9)

  • Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20. doi: 10.1097/00000542-199911000-00045.

    PMID: 10551604BACKGROUND
  • Auroy Y, Ecoffey C, Messiah A, Rouvier B. Relationship between complications of pediatric anesthesia and volume of pediatric anesthetics. Anesth Analg. 1997 Jan;84(1):234-5. doi: 10.1097/00000539-199701000-00060. No abstract available.

    PMID: 8989044BACKGROUND
  • Harless J, Ramaiah R, Bhananker SM. Pediatric airway management. Int J Crit Illn Inj Sci. 2014 Jan;4(1):65-70. doi: 10.4103/2229-5151.128015.

    PMID: 24741500BACKGROUND
  • Von Ungern-Sternberg BS, Habre W. Pediatric anesthesia - potential risks and their assessment: part I. Paediatr Anaesth. 2007 Mar;17(3):206-15. doi: 10.1111/j.1460-9592.2006.02097.x. No abstract available.

    PMID: 17263734BACKGROUND
  • Burns KE, Duffett M, Kho ME, Meade MO, Adhikari NK, Sinuff T, Cook DJ; ACCADEMY Group. A guide for the design and conduct of self-administered surveys of clinicians. CMAJ. 2008 Jul 29;179(3):245-52. doi: 10.1503/cmaj.080372. No abstract available.

    PMID: 18663204BACKGROUND
  • van Gelder MM, Bretveld RW, Roeleveld N. Web-based questionnaires: the future in epidemiology? Am J Epidemiol. 2010 Dec 1;172(11):1292-8. doi: 10.1093/aje/kwq291. Epub 2010 Sep 29.

    PMID: 20880962BACKGROUND
  • Kelley K, Clark B, Brown V, Sitzia J. Good practice in the conduct and reporting of survey research. Int J Qual Health Care. 2003 Jun;15(3):261-6. doi: 10.1093/intqhc/mzg031.

    PMID: 12803354BACKGROUND
  • Tait AR, Voepel-Lewis T. Survey research: it's just a few questions, right? Paediatr Anaesth. 2015 Jul;25(7):656-62. doi: 10.1111/pan.12680. Epub 2015 Apr 30.

    PMID: 25929546BACKGROUND
  • Hohne C, Haack M, Machotta A, Kaisers U. [Airway management in pediatric anesthesia]. Anaesthesist. 2006 Jul;55(7):809-19; quiz 820. doi: 10.1007/s00101-006-1045-0. German.

    PMID: 16804684BACKGROUND

Study Officials

  • Antonio Braschi, MD Prof

    IRCCS Policlinico San Matteo

    STUDY CHAIR

Central Study Contacts

Thekla L Niebel, MD PhD

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 22, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations