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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02810288
Other study ID # AR-01-SUR-AMPA
Secondary ID
Status Recruiting
Phase N/A
First received June 14, 2016
Last updated June 22, 2016
Start date January 2016
Est. completion date March 2017

Study information

Verified date June 2016
Source IRCCS Policlinico S. Matteo
Contact Thekla L Niebel, MD PhD
Phone 0039349
Email thekla.niebel@gmail.com
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial 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.


Description:

Airway management is one of the key areas of paediatric anaesthesia practice. The paediatric patients have significant anatomical and physiological differences compared with adults, which impact on the techniques and tools that the anaesthesiologist might choose to provide safe and effective control of the airway. Furthermore, there are a number of pathological processes, typically seen in the paediatric population, which present unique anatomical or functional difficulties in airway management. The presence of one of these syndromes or conditions can predict a "difficult airway".

Respiratory adverse events continue to be the leading reason for perioperative critical events in children. New developments in airway management in paediatric patients can only improve perioperative outcome if anaesthesiologists who are fully acquainted with these fundamental aspects of paediatric anaesthesia care for these children.

This survey was taken out within members of the Community of European Anaesthesiologists, to describe and explore current patterns of their airway management in paediatric anaesthesia.

The purpose of the study was to see whether there are more uniform practice patterns among anaesthesiologist with paediatric experience than those without paediatric experience.

Secondarily, the survey also explored anaesthetists'' knowledge about the risks of respiratory adverse events and, and about national organizations' recommendations.

Therefore, this survey highlighted some of the important anatomical and physiological differences and their implication in daily anaesthesiological practice.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Anaesthesiologists currently working in the operating rooms.

Exclusion Criteria:

- unwilling to join the study

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Behavioral:
Voluntarily response all items in the questionnaire.
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.

Locations

Country Name City State
Italy IRCCS Policlinico San Matteo Pavia

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. Review. — View Citation

Clergue F, Auroy Y, Péquignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20. — View Citation

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. — View Citation

Höhne C, Haack M, Machotta A, Kaisers U. [Airway management in pediatric anesthesia]. Anaesthesist. 2006 Jul;55(7):809-19; quiz 820. Review. German. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Von Ungern-Sternberg BS, Habre W. Pediatric anesthesia - potential risks and their assessment: part I. Paediatr Anaesth. 2007 Mar;17(3):206-15. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Proportion of anaesthesiologist with paediatric experience measuring cuff pressure with pressure manometer compared to those without paediatric experience. The 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 No
Secondary Proportion of participants correctly identifying predictability of difficult airway in children. To assess variables associated to adoption of standard practice, in particular: knowledge of the anatomical, physiological, and pathological features related to the airway. A time of survey; generally less than 20 minutes No
Secondary Proportion of participants correctly answering questions about the use of (modified) rapid sequence induction in the paediatric population. To compare anaesthesiologists with and without paediatric experience in terms of different practice patterns, and items explored by the questionnaire. A time of survey; generally less than 20 minutes No
Secondary Proportion of anaesthesiologist correctly identifying national organisations difficult airway recommendations. To informally compare practiced elicited within this study to existing guidelines and algorithms in paediatric anaesthesia. A time of survey; generally less than 20 minutes No
See also
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