Intubation; DifficultNCT03035786
Airway Code Calls - Survey of Management
An observational study of Intubation; Difficult, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive Care Unit, SICU). The anaesthetists are doctors trained in advance airway management. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Intubation; Difficult
- How many people
- 300 participants
- Where
- 2 sitesSingapore
- Study dates
- Nov 2016to Nov 2018
- How long will I take part?
- 1 Day
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All 'airway code' requests for emergency anaesthetic airway support for adults outside operating theatre and Surgical Intensive Care Unit.
Who may be able to join
- adults outside operating theatre and Surgical Intensive Care Unit requiring emergency anaesthetic airway support
Who cannot join
- Nil
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, Singapore, 169608
Patrick Wong, FRCA, 63214220, patrick.wong@singhealth.com.sg
Zihui Tan, MMED, 63214220, zihui.tan@mohh.com.sg
- Recruiting
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Jinbin Zhang, MMED, 62566011, Jinbin_Zhang@ttsh.com.sg
About this study
This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive Care Unit, SICU).
The anaesthetists are doctors trained in advance airway management. Patients in the hospital may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway code by attending the patient in need and managing the patient at their own discretion.
Read more
Airway management will depend on the anaesthetist's knowledge, skills and experience. it will also depend on the available airway equipment.
We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident; patient factors (including airway assessment); type of equipment used; anaesthetic drugs used; airway management chosen by the attending anaesthetist; and, airway complications.
Read the detailed description
Airway codes will be managed as standard care. These calls are taken and managed by anaesthetists on call on SICU. The audit form is filled in by the on call anaesthetist after the airway code has been managed. This is an audit looking at:
Primary outcome
•Evaluate the type of airway codes that the SICU anaesthetist is called for
Secondary outcomes:
- Patient factors (including airway assessment)
- Type of equipment used
- Type of anaesthetic drugs used
- Airway management chosen by the attending anaesthetist
- Airway complications.
- Conditions
- Intubation; Difficult
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey the type of airway codes that the SICU anaesthetist is called for
Cause of airway codes i.e. respiratory arrest or indication for formal airway management by anaesthetist
Measured: One hour post calling of airway code
Secondary outcomes (2)
Survey of types of equipment needed for airway management
Type of equipment used include airway bag, bougie, videolaryngoscope
Measured: One hour post calling of airway code
Number of participants with predictors of difficult airway
Predictors of difficult airway include small mouth opening, short thyromental distance, prominent upper teeth, receding lower jaw, decreased neck movement, previous surgery, previous radiotherapy
Measured: One hour post calling of airway code
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Responsible party
- Sponsor
- Investigators
- Patrick Wong, MBBS FRCA, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035786
- Sponsor's protocol ID
- 1607 Airway Code
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bowles TM, Freshwater-Turner DA, Janssen DJ, Peden CJ; RTIC Severn Group. Out-of-theatre tracheal intubation: prospective multicentre study of clinical practice and adverse events. Br J Anaesth. 2011 Nov;107(5):687-92. doi: 10.1093/bja/aer251. Epub 2011 Aug 8.
PubMed 21828342Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
PubMed 21150574
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Code Calls - Survey of Management
- ClinicalTrials.gov ID
- NCT03035786
- Acronym / sponsor ID
- 1607 Airway Code
- Conditions
- Intubation; Difficult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 Jan 2017 (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.
This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive Care Unit, SICU).
The anaesthetists are doctors trained in advance airway management. Patients in the hospital may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway code by attending the patient in need and managing the patient at their own discretion.
Airway management will depend on the anaesthetist's knowledge, skills and experience. it will also depend on the available airway equipment.
We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident; patient factors (including airway assessment); type of equipment used; anaesthetic drugs used; airway management chosen by the attending anaesthetist; and, airway complications.
Detailed description
Airway codes will be managed as standard care. These calls are taken and managed by anaesthetists on call on SICU. The audit form is filled in by the on call anaesthetist after the airway code has been managed. This is an audit looking at:
Primary outcome
•Evaluate the type of airway codes that the SICU anaesthetist is called for
Secondary outcomes:
- Patient factors (including airway assessment)
- Type of equipment used
- Type of anaesthetic drugs used
- Airway management chosen by the attending anaesthetist
- Airway complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All 'airway code' requests for emergency anaesthetic airway support for adults outside operating theatre and Surgical Intensive Care Unit.
Key inclusion criteria (1 listed)
- adults outside operating theatre and Surgical Intensive Care Unit requiring emergency anaesthetic airway support
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey the type of airway codes that the SICU anaesthetist is called for
Time frame: One hour post calling of airway code
Cause of airway codes i.e. respiratory arrest or indication for formal airway management by anaesthetist
2 secondary outcomes
Survey of types of equipment needed for airway management
Time frame: One hour post calling of airway code
Number of participants with predictors of difficult airway
Time frame: One hour post calling of airway code
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Background: PubMed 21828342Bowles TM, Freshwater-Turner DA, Janssen DJ, Peden CJ; RTIC Severn Group. Out-of-theatre tracheal intubation: prospective multicentre study of clinical practice and adverse events. Br J Anaesth. 2011 Nov;107(5):687-92. doi: 10.1093/bja/aer251. Epub 2011 Aug 8.
- Background: PubMed 21150574Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
- 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.
Patrick Wong, MBBS FRCA principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult, run by Singapore General Hospital at 2 sites in Singapore.
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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 Patrick Wong, MBBS FRCA (+6563214220, patrick.wong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey the type of airway codes that the SICU anaesthetist is called for (time frame: One hour post calling of airway code). 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 NCT03035786, which also lists 2 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 30 Jan 2017.