TracheostomyNCT01356719
Scoring Method for Describing the Position of a Tracheostomy Tube
An observational study of Tracheostomy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Tracheostomies are artificial airway devices inserted into the neck. They can become displaced and lead to patient harm. Other than external visual inspection, there is no currently described system for describing the position of a tracheostomy tube within the airway. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Tracheostomy
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Feb 2012
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults (>16yrs) who have a tracheostomy performed as part of their intensive care management
Who may be able to join
- Adults >16 years old
- Presence of a percutaneous or surgical tracheostomy
- Patient being cared for in the AICU of UHSM
Who cannot join
- Endoscopy not clinically appropriate (in the opinion of the attending physician)
- Refusal by patient or their representative
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of South Manchester
Manchester, M23 9LT
About this study
Official title: LUNAR Study - Develop and Validate a Bedside Scoring Method for Describing the Position and Orientation of a Tracheostomy Tube Tip When Viewed Endoscopically From a Standardised Position
Tracheostomies are artificial airway devices inserted into the neck. They can become displaced and lead to patient harm. Other than external visual inspection, there is no currently described system for describing the position of a tracheostomy tube within the airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube with a small fibre-optic camera from above and also through the tube to visualise its position within the airway. The investigators will take anonymised paired images and then score these using 6 different scoring systems. The investigators will determine which scoring system provides the simplest and most reproducible scores between 6 blinded assessors. A clinically useful scoring system could be used in future to predict problems with tracheostomy positioning.
Read the detailed description
Aims \& Outcomes
- Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position
- Secondary aims
- Correlate the endoscopic views of the tracheostomy tube with the trans-laryngeal views.
- Is it possible to predict the trans-laryngeal view from the endoscopic view.
- Does the position of a tracheostomy tube tip change when the patient is repositioned following percutaneous tracheostomy (when viewed endoscopically)
- Equipment training: Compare the number of supervised endoscopies required to consistently achieve the required standardised view
- Primary outcome
- Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
- Secondary outcome
- Assess correlation between the best scoring system (chosen by above) with the translaryngeal view
- Tertiary aim - Assessment of training: Determine the number of attempts required to obtain adequate standardised views. This will be a manikin based assessment to demonstrate competence in performing the endoscopies for the study before any procedures are undertaken on patients.
- Conditions
- Tracheostomy
- Keywords
- Tracheostomy, adverse effects, Critical Care, standards, safety
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Brendan A McGrath, MB ChB, Principal investigator, University Hospital of South Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356719
- Sponsor's protocol ID
- LUNAR2011
- Status last verified
- May 2020
- First submitted
- 16 May 2011
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
McGrath BA, Lynch K, Templeton R, Webster K, Simpson W, Alexander P, Columb MO. Assessment of scoring systems to describe the position of tracheostomy tubes within the airway - the lunar study. Br J Anaesth. 2017 Jan;118(1):132-138. doi: 10.1093/bja/aew336.
PubMed 28039250
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUNAR Study - Develop and Validate a Bedside Scoring Method for Describing the Position and Orientation of a Tracheostomy Tube Tip When Viewed Endoscopically From a Standardised Position
- ClinicalTrials.gov ID
- NCT01356719
- Acronym / sponsor ID
- LUNAR2011
- Conditions
- Tracheostomy
- Keywords
- Tracheostomy, adverse effects, Critical Care, standards, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Jul 2011 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 May 2011 (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.
Tracheostomies are artificial airway devices inserted into the neck. They can become displaced and lead to patient harm. Other than external visual inspection, there is no currently described system for describing the position of a tracheostomy tube within the airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube with a small fibre-optic camera from above and also through the tube to visualise its position within the airway. The investigators will take anonymised paired images and then score these using 6 different scoring systems. The investigators will determine which scoring system provides the simplest and most reproducible scores between 6 blinded assessors. A clinically useful scoring system could be used in future to predict problems with tracheostomy positioning.
Detailed description
Aims \& Outcomes
- Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position
- Secondary aims
- Correlate the endoscopic views of the tracheostomy tube with the trans-laryngeal views.
- Is it possible to predict the trans-laryngeal view from the endoscopic view.
- Does the position of a tracheostomy tube tip change when the patient is repositioned following percutaneous tracheostomy (when viewed endoscopically)
- Equipment training: Compare the number of supervised endoscopies required to consistently achieve the required standardised view
- Primary outcome
- Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
- Secondary outcome
- Assess correlation between the best scoring system (chosen by above) with the translaryngeal view
- Tertiary aim - Assessment of training: Determine the number of attempts required to obtain adequate standardised views. This will be a manikin based assessment to demonstrate competence in performing the endoscopies for the study before any procedures are undertaken on patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults (>16yrs) who have a tracheostomy performed as part of their intensive care management
Key inclusion criteria (3 listed)
- Adults >16 years old
- Presence of a percutaneous or surgical tracheostomy
- Patient being cared for in the AICU of UHSM
Key exclusion criteria (2 listed)
- Endoscopy not clinically appropriate (in the opinion of the attending physician)
- Refusal by patient or their representative
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
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
Time frame: 6 months
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 28039250McGrath BA, Lynch K, Templeton R, Webster K, Simpson W, Alexander P, Columb MO. Assessment of scoring systems to describe the position of tracheostomy tubes within the airway - the lunar study. Br J Anaesth. 2017 Jan;118(1):132-138. doi: 10.1093/bja/aew336.
- Related InfoLink provided by the sponsor.
Related trials for Tracheostomy
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients
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.
Brendan A McGrath, MB ChB principal investigator
University Hospital of South Manchester
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 Tracheostomy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jun 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients. (time frame: 6 months). 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 NCT01356719, which also lists 1 linked publication.
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 1 Jun 2020.