Paediatric Airway ManagementSUR-AMPANCT02810288
Airway Management Practice Patterns in Paediatric Anaesthesia: A Survey
An observational study of Paediatric Airway Management, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Paediatric Airway Management
- What is being tested?
- Voluntarily response all items in the questionnaire.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Anaesthesiologists currently working in the operating rooms.
Who cannot join
- unwilling to join the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Thekla L Niebel, MD PhD, 00390382 ext. 503477, thekla.niebel@smatteo.pv.it
About this study
Official title: A Survey of Airway Management Practice Patterns in Paediatric Anaesthesia by Anaesthesiologists in Different European Hospitals
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.
Read the detailed 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.
- Conditions
- Paediatric Airway Management
- Being tested
- Voluntarily response all items in the questionnaire.
- Keywords
- Airway anatomy, difficult intubation, congenital syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntarily response all items in the questionnaire.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Expert | Anaesthesiologist with large paediatric daily practice. All participant voluntarily response all items in the questionnaire database. Receives: 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. Receives: Behavioral: Voluntarily response all items in the questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The objective will be to compare anaesthesiologists with and without paediatric experience in terms of proportion of anaesthesiologists adopting "standard" practice.
Measured: A time of survey; generally less than 20 minutes
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.
Measured: 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.
To compare anaesthesiologists with and without paediatric experience in terms of different practice patterns, and items explored by the questionnaire.
Measured: A time of survey; generally less than 20 minutes
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.
Measured: A time of survey; generally less than 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Paediatric Airway ManagementStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thekla Niebel, MD PhD, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Antonio Braschi, MD Prof, Study chair, IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810288
- Sponsor's protocol ID
- AR-01-SUR-AMPA
- Acronym
- SUR-AMPA
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 10551604Auroy 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.
PubMed 8989044Harless 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.
PubMed 24741500Von 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.
PubMed 17263734Burns 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.
PubMed 18663204van 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.
PubMed 20880962Kelley 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.
PubMed 12803354Tait 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.
PubMed 25929546Hohne 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.
PubMed 16804684
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Airway Management Practice Patterns in Paediatric Anaesthesia by Anaesthesiologists in Different European Hospitals
- ClinicalTrials.gov ID
- NCT02810288
- Acronym / sponsor ID
- SUR-AMPA / AR-01-SUR-AMPA
- Conditions
- Paediatric Airway Management
- Keywords
- Airway anatomy, difficult intubation, congenital syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert | – | Behavioral: Voluntarily response all items in the questionnaire.Anaesthesiologist with large paediatric daily practice. All participant voluntarily response all items in the questionnaire database. |
| Non-experts | – | Behavioral: Voluntarily response all items in the questionnaire.Anaesthesiologist with little paediatric daily practice. All participant voluntarily response all items in the questionnaire database. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Anaesthesiologists currently working in the operating rooms.
Key exclusion criteria (1 listed)
- unwilling to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Expert, Non-experts |
Primary outcome
Proportion of anaesthesiologist with paediatric experience using intravenous induction compared to those without paediatric experience.
Time frame: A time of survey; generally less than 20 minutes
The primary objective will be to compare anaesthesiologists with and without paediatric experience in terms of proportion of anaesthesiologists adopting "standard" practice.
4 secondary outcomes
Proportion of anaesthesiologist with paediatric experience measuring cuff pressure with pressure manometer compared to those without paediatric experience.
Time frame: A time of survey; generally less than 20 minutes
Proportion of participants correctly identifying predictability of difficult airway in children.
Time frame: 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.
Time frame: A time of survey; generally less than 20 minutes
Proportion of anaesthesiologist correctly identifying national organisations difficult airway recommendations.
Time frame: A time of survey; generally less than 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Background: PubMed 10551604Clergue 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.
- Background: PubMed 8989044Auroy 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.
- Background: PubMed 24741500Harless 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.
- Background: PubMed 17263734Von 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.
- Background: PubMed 18663204Burns 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.
- Background: PubMed 20880962van 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.
- Background: PubMed 12803354Kelley 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.
- Background: PubMed 25929546Tait 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.
- Background: PubMed 16804684Hohne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Braschi, MD Prof study chair
IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Airway Management, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thekla L Niebel, MD PhD (0039349 ext. 8513800, thekla.niebel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of anaesthesiologist with paediatric experience using intravenous induction compared to those without paediatric experience. (time frame: A time of survey; generally less than 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810288, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.