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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United Kingdom

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:

  1. Video-camera recording one metre away from the side of the patient's head and neck.
  2. Photographic still shots at the moment of laryngoscopy from the foot of the bed/trolley.
  3. 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.

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 groups in NCT02167477
Study groupRoleWhat they receive
Laryngoscopy sequence 1Active comparatorMacintosh 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 2Active comparatorMacintosh 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.

  1. 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)
  1. Subjective "ease of intubation"

    Measured: one year

  2. 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.

  1. First posted19 Jun 2014 (estimated)
  2. Study startJan 2013
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Resources

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)
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

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.

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