OBESITY, MORBIDNCT02167477
Comparison of Indirect and Direct Laryngoscopy in Obese Patients
A study testing Macintosh laryngoscopy, Storz C-MAC, standard blade and Storz C-MAC, D-BLADE in people with OBESITY, MORBID and BARIATRIC SURGERY CANDIDATE, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
An anaesthetist inserts a "laryngoscope" into the mouth to see the voice-box (larynx) for "tracheal intubation", when a tube is advanced into the windpipe (trachea) to protect the airway and administer anaesthetic gases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OBESITY, MORBID, BARIATRIC SURGERY CANDIDATE
- What is being tested?
- Macintosh laryngoscopy, Storz C-MAC, standard blade and Storz C-MAC, D-BLADE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to 7 Jan 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients (BMI >35) for elective bariatric surgery
Who cannot join
- Patients in whom rapid sequence induction of anaesthesia is indicated
- Patients in whom the responsible anaesthetist considers conventional laryngoscopy inappropriate (e.g. when the mouth opening is too narrow)
- Patients whose comorbidity makes them unsuitable for this type of study (e.g. those with limited cardiopulmonary reserve)
- patients who do not consent to be involved in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aintree University Hospitals
Liverpool, Merseyside, L9 7AL
About this study
Official title: Comparison of the C-MAC Video Laryngoscope With Conventional Direct Laryngoscopy in Morbidly Obese Patients Using a Photographic Overlay Technique
An anaesthetist inserts a "laryngoscope" into the mouth to see the voice-box (larynx) for "tracheal intubation", when a tube is advanced into the windpipe (trachea) to protect the airway and administer anaesthetic gases.
This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel "photographic overlay technique" to analyse the basis for any differences.
Read the detailed description
The aim is to have 40 patients complete the protocol. This number is based on a recent similar study at Aintree hospital where this number of cases was successfully used to make multiple parameter comparisons between different videolaryngoscope blades during Ear Nose and Throat (ENT) procedures. Following the template of this earlier work all the patients will have three laryngoscopy assessments.
When seen in the preoperative clinic, patients will be informed about the study and given a patient information sheet to take home. On the day of admission for surgery they will be asked for their consent to be involved in the study by the study researchers.
Prior to theatre, the research team will make a number of straightforward external measurements. Various surface markings around the head and neck of the patients will be applied immediately before proceeding to the operating theatre. In the anaesthetic room, prior to induction of anaesthesia, the patients will have standard monitoring attached (including oxygen saturations, electrocardiograph and non-invasive blood pressure). They will be positioned as usual by the anaesthetist in charge of the case. The monitoring of the laryngoscopy will comprise:
- Video-camera recording one metre away from the side of the patient's head and neck.
- Photographic still shots at the moment of laryngoscopy from the foot of the bed/trolley.
- View of laryngoscopy itself via the optical systems in the C-MAC® video laryngoscopes The photographs taken from the foot of the bed/trolley are to note any lateral rotation in the head position during laryngoscopy. Should this occur it may need to be allowed for in the processing of the photographic overlay analysis during processing of the lateral images.
The anaesthetic technique will be standardised. After 3 mins of pre-oxygenation with a face mask, anaesthesia is induced with Remifentanil (technique for administration will be decided by the individual anaesthetist), Propofol 1.5-2.5 mg/kg and neuromuscular blockade with Rocuronium 0.6 mg/kg before airway manipulation. Bag mask ventilation with 100% oxygen and volatile anaesthetic will be performed prior to and between each of the three laryngoscopy assessments. The patient will be monitored closely for any adverse signs, if at any point the oxygen saturations fall below 90% the patient will be withdrawn from the study and anaesthesia continued as deemed appropriate by the responsible clinician. During each laryngoscopy the anaesthetist will indicate when the moment of maximal laryngoscopic view is obtained so that this can be recorded by the video devices. In the case of Macintosh, the observed percentage of glottic opening or POGO score will be documented. If an inadequate view is found the clinician may have one attempt at improving the view with cricoid pressure which will again be recorded. The conventional Macintosh laryngoscope will always be used for the first laryngoscopy. The sequence of the second and third laryngoscopies will be decided by block randomisation. Tracheal intubation will be undertaken during the final laryngoscopy. A shaped metallic stylet will be place within the tracheal tube as an intubation aid in all patients intubated with the C-MAC® D-BLADE video laryngoscope. Following intubation, an endoscopic examination of the posterior wall of the pharynx will be undertaken as the videolaryngoscope is withdrawn to ensure no trauma has been caused by the intubation. Following intubation, the patient will then continue with anaesthesia and surgery as planned. There will be monitoring of the patient closely in recovery and post-operatively as part of normal clinical care.
Off-line data analysis will consist of superposition of the videolaryngoscope blade shape outlines on the lateral photographic images. The POGO scores will be compared with the preoperative measurements and the relevant results from the overlay imaging analysis.
- Conditions
- OBESITY, MORBID, BARIATRIC SURGERY CANDIDATE
- Being tested
- Macintosh laryngoscopy, Storz C-MAC, standard blade, Storz C-MAC, D-BLADE
- Keywords
- Intubation, Endotracheal
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopyDevice
Tracheal intubation
Storz C-MAC, standard bladeDevice
Tracheal intubation
Storz C-MAC, D-BLADEDevice
Tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy sequence 1 | Active comparator | Macintosh laryngoscopy Storz C-MAC, standard blade Storz C-MAC, D-BLADE Receives: Device: Macintosh laryngoscopy; Device: Storz C-MAC, standard blade; Device: Storz C-MAC, D-BLADE |
| Laryngoscopy sequence 2 | Active comparator | Macintosh Storz C-MAC, D-BLADE Storz C-MAC, standard blade Receives: Device: Macintosh laryngoscopy; Device: Storz C-MAC, standard blade; Device: Storz C-MAC, D-BLADE |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO (percentage of glottic opening) score at maximum laryngeal view for three laryngoscopes (Macintosh, Storz C-MAC, standard and D-BLADE)
Measured: one year
Secondary outcomes (2)
Subjective "ease of intubation"
Measured: one year
Time to intubate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2013
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
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 OBESITY, MORBIDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Peter Charters, Principal investigator, Aintree University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167477
- Sponsor's protocol ID
- 12/NW/0805
- Status last verified
- Mar 2016
- First submitted
- 17 Jun 2014
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charters P. Analysis of mathematical model for osseous factors in difficult intubation. Can J Anaesth. 1994 Jul;41(7):594-602. doi: 10.1007/BF03009999.
PubMed 8087908
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the C-MAC Video Laryngoscope With Conventional Direct Laryngoscopy in Morbidly Obese Patients Using a Photographic Overlay Technique
- ClinicalTrials.gov ID
- NCT02167477
- Acronym / sponsor ID
- 12/NW/0805
- Conditions
- OBESITY, MORBID, BARIATRIC SURGERY CANDIDATE
- Keywords
- Intubation, Endotracheal
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Imperial College London
- Study start
- Jan 2013
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 19 Jun 2014 (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.
An anaesthetist inserts a "laryngoscope" into the mouth to see the voice-box (larynx) for "tracheal intubation", when a tube is advanced into the windpipe (trachea) to protect the airway and administer anaesthetic gases.
This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel "photographic overlay technique" to analyse the basis for any differences.
Detailed description
The aim is to have 40 patients complete the protocol. This number is based on a recent similar study at Aintree hospital where this number of cases was successfully used to make multiple parameter comparisons between different videolaryngoscope blades during Ear Nose and Throat (ENT) procedures. Following the template of this earlier work all the patients will have three laryngoscopy assessments.
When seen in the preoperative clinic, patients will be informed about the study and given a patient information sheet to take home. On the day of admission for surgery they will be asked for their consent to be involved in the study by the study researchers.
Prior to theatre, the research team will make a number of straightforward external measurements. Various surface markings around the head and neck of the patients will be applied immediately before proceeding to the operating theatre. In the anaesthetic room, prior to induction of anaesthesia, the patients will have standard monitoring attached (including oxygen saturations, electrocardiograph and non-invasive blood pressure). They will be positioned as usual by the anaesthetist in charge of the case. The monitoring of the laryngoscopy will comprise:
- Video-camera recording one metre away from the side of the patient's head and neck.
- Photographic still shots at the moment of laryngoscopy from the foot of the bed/trolley.
- View of laryngoscopy itself via the optical systems in the C-MAC® video laryngoscopes The photographs taken from the foot of the bed/trolley are to note any lateral rotation in the head position during laryngoscopy. Should this occur it may need to be allowed for in the processing of the photographic overlay analysis during processing of the lateral images.
The anaesthetic technique will be standardised. After 3 mins of pre-oxygenation with a face mask, anaesthesia is induced with Remifentanil (technique for administration will be decided by the individual anaesthetist), Propofol 1.5-2.5 mg/kg and neuromuscular blockade with Rocuronium 0.6 mg/kg before airway manipulation. Bag mask ventilation with 100% oxygen and volatile anaesthetic will be performed prior to and between each of the three laryngoscopy assessments. The patient will be monitored closely for any adverse signs, if at any point the oxygen saturations fall below 90% the patient will be withdrawn from the study and anaesthesia continued as deemed appropriate by the responsible clinician. During each laryngoscopy the anaesthetist will indicate when the moment of maximal laryngoscopic view is obtained so that this can be recorded by the video devices. In the case of Macintosh, the observed percentage of glottic opening or POGO score will be documented. If an inadequate view is found the clinician may have one attempt at improving the view with cricoid pressure which will again be recorded. The conventional Macintosh laryngoscope will always be used for the first laryngoscopy. The sequence of the second and third laryngoscopies will be decided by block randomisation. Tracheal intubation will be undertaken during the final laryngoscopy. A shaped metallic stylet will be place within the tracheal tube as an intubation aid in all patients intubated with the C-MAC® D-BLADE video laryngoscope. Following intubation, an endoscopic examination of the posterior wall of the pharynx will be undertaken as the videolaryngoscope is withdrawn to ensure no trauma has been caused by the intubation. Following intubation, the patient will then continue with anaesthesia and surgery as planned. There will be monitoring of the patient closely in recovery and post-operatively as part of normal clinical care.
Off-line data analysis will consist of superposition of the videolaryngoscope blade shape outlines on the lateral photographic images. The POGO scores will be compared with the preoperative measurements and the relevant results from the overlay imaging analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy sequence 1 | Active comparator | Device: Macintosh laryngoscopy, Device: Storz C-MAC, standard blade, Device: Storz C-MAC, D-BLADEMacintosh laryngoscopy Storz C-MAC, standard blade Storz C-MAC, D-BLADE |
| Laryngoscopy sequence 2 | Active comparator | Device: Macintosh laryngoscopy, Device: Storz C-MAC, standard blade, Device: Storz C-MAC, D-BLADEMacintosh Storz C-MAC, D-BLADE Storz C-MAC, standard blade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese patients (BMI >35) for elective bariatric surgery
Key exclusion criteria (4 listed)
- Patients in whom rapid sequence induction of anaesthesia is indicated
- Patients in whom the responsible anaesthetist considers conventional laryngoscopy inappropriate (e.g. when the mouth opening is too narrow)
- Patients whose comorbidity makes them unsuitable for this type of study (e.g. those with limited cardiopulmonary reserve)
- patients who do not consent to be involved in 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 |
|---|---|---|
| Macintosh laryngoscopyTracheal intubation | Device | Laryngoscopy sequence 1, Laryngoscopy sequence 2 |
| Storz C-MAC, standard bladeTracheal intubation | Device | Laryngoscopy sequence 1, Laryngoscopy sequence 2 |
| Storz C-MAC, D-BLADETracheal intubation | Device | Laryngoscopy sequence 1, Laryngoscopy sequence 2 |
Primary outcome
POGO (percentage of glottic opening) score at maximum laryngeal view for three laryngoscopes (Macintosh, Storz C-MAC, standard and D-BLADE)
Time frame: one year
2 secondary outcomes
Subjective "ease of intubation"
Time frame: one year
Time to intubate
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 8087908Charters P. Analysis of mathematical model for osseous factors in difficult intubation. Can J Anaesth. 1994 Jul;41(7):594-602. doi: 10.1007/BF03009999.
- 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.
Peter Charters principal investigator
Aintree University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscopy, Storz C-MAC, standard blade and Storz C-MAC, D-BLADE in people with OBESITY, MORBID and BARIATRIC SURGERY CANDIDATE, run by Liverpool University Hospitals 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
POGO (percentage of glottic opening) score at maximum laryngeal view for three laryngoscopes (Macintosh, Storz C-MAC, standard and D-BLADE) (time frame: one year). 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 NCT02167477, 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 9 Jun 2022.