Intubation;DifficultNCT03341507

Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method

A study testing classical laryngoscopy and rigid tube for laryngoscopy in people with Intubation;Difficult, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal intubation in patients with presumed difficult airway and compare the classical laryngoscopy and this method in matter of glottis visualisation and tracheal intubation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Intubation;Difficult
What is being tested?: classical laryngoscopy and rigid tube for laryngoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteRomania
Study dates: 1 Feb 2017to 7 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis
patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery

Who cannot join

stridor or marked laryngeal or tracheal stenosis, vocal cords polyps
emergency surgery, decompensated cardiac or pulmonary disease
grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

Trial locations and contacts

1 site in 1 country.

Romania1 site

Cluj County Emergency Hospital- ENT Clinic
Cluj-Napoca, Cluj, 400006

Other trials in Romania

About this study

Official title: A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients

Read the detailed description

The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a light source.

The hypothesis of the study stands that the rigid tube for laryngoscopy could be more efficient in tracheal intubation for difficult airway patients when the classical intubation with a curved blade laryngoscope is unsatisfactory.

The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

Conditions: Intubation;Difficult
Being tested: classical laryngoscopy, rigid tube for laryngoscopy
Keywords: laryngoscopy, retromolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

classical laryngoscopyDevice
Also called laryngoscopy with McIntosh curved blade laryngoscope
the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.
rigid tube for laryngoscopyDevice
the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed

Study groups in NCT03341507
Study group	Role	What they receive
laryngoscopy and tracheal intubation	Experimental	Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed. Receives: Device: classical laryngoscopy; Device: rigid tube for laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Tracheal Intubation With the Rigid Tube
the time from starting to use the rigid tube for laryngoscopy until the airway was secured.
Measured: 120 seconds

Secondary outcomes (2)

Complications During Intubation With Rigid Tube
complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%
Measured: 5 minutes
Late Complications of Intubation With Rigid Tube
complications noticed following the use of rigid tube - sore throat, upper lip injury.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20177 Dec 2019

First posted14 Nov 2017
Study start1 Feb 2017
Primary completion1 Dec 2019
Study completion7 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A group of patients with difficult airway criteria will be intubated using the rigid tube for laryngoscopy. A classical laryngoscopy with a McIntosh laryngoscope will be performed prior intubation and the Cormack-Lehane grade of glottis visualisation will be noted. If the Cormack -Lehane grade of glotic visualisation 2b, 3 or 4, the intubation maneuvre is carried further with the rigid tube. If the Cormack-Lehane glottic visualisation grade is less than 2b (1 or 2a) the intubation is accomplished with the MacIntosh laryngoscope (conventional laryngoscope) and the patient is excluded from the study from that point further.
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03341507
Sponsor's protocol ID: MIFlorin
Status last verified: Mar 2021
First submitted: 3 Nov 2017
Last updated: 9 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Norskov AK, Rosenstock CV, Wetterslev J, Lundstrom LH. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. Trials. 2013 Oct 23;14:347. doi: 10.1186/1745-6215-14-347.
PubMed 24152537
Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available.
PubMed 9349093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
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Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
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Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation

All Intubation;Difficult trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients
ClinicalTrials.gov ID: NCT03341507
Acronym / sponsor ID: MIFlorin
Conditions: Intubation;Difficult
Keywords: laryngoscopy, retromolar
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
Study start: 1 Feb 2017 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 7 Dec 2019 (actual)
First posted: 14 Nov 2017 (actual)
Results: Posted 8 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A group of patients with difficult airway criteria will be intubated using the rigid tube for laryngoscopy. A classical laryngoscopy with a McIntosh laryngoscope will be performed prior intubation and the Cormack-Lehane grade of glottis visualisation will be noted. If the Cormack -Lehane grade of glotic visualisation 2b, 3 or 4, the intubation maneuvre is carried further with the rigid tube. If the Cormack-Lehane glottic visualisation grade is less than 2b (1 or 2a) the intubation is accomplished with the MacIntosh laryngoscope (conventional laryngoscope) and the patient is excluded from the study from that point further.

Arm	Type	Receives
laryngoscopy and tracheal intubation	Experimental	Device: classical laryngoscopy, Device: rigid tube for laryngoscopyTracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis
patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery

Key exclusion criteria (3 listed)

stridor or marked laryngeal or tracheal stenosis, vocal cords polyps
emergency surgery, decompensated cardiac or pulmonary disease
grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

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
classical laryngoscopyAlso: laryngoscopy with McIntosh curved blade laryngoscopethe laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.	Device	laryngoscopy and tracheal intubation
rigid tube for laryngoscopythe view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed	Device	laryngoscopy and tracheal intubation

Primary outcome

Time to Tracheal Intubation With the Rigid Tube
Time frame: 120 seconds
the time from starting to use the rigid tube for laryngoscopy until the airway was secured.

2 secondary outcomes

Complications During Intubation With Rigid Tube
Time frame: 5 minutes
Late Complications of Intubation With Rigid Tube
Time frame: 3 days

Results and safety

Results posted to the registry on 8 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laryngoscopy and Tracheal Intubation	64	30

Primary outcome: Time to Tracheal Intubation With the Rigid Tube

Time frame: 120 seconds. Median (Inter-Quartile Range). Unit: seconds

Measure	Laryngoscopy and Tracheal Intubation n = 30
Value	50.5 (38 to 67)

Population analysed: Patients with a Cormack-Lehane grade 2b,3 or 4 during conventional laryngoscopy who had their airways secured with a rigid tube. Patients with a a Cormack-Lehane grade 1 and 2a were intubated with the curved blade laryngoscope and they were not included in analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: complications noticed during and following the use of rigid tube : time frame-3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laryngoscopy and Tracheal Intubation	1 of 64 (1.6%)	5 of 64 (7.8%)	0 of 64

Limitations and caveats (from the sponsor): This is an observational single-center study that relies on personal perception and the skill of a limited number of investigators. To master the rigid tube a period of training and regular use is needed. The major disadvantage of the rigid tube for laryngoscopy is the reduced visual field which can be improved by increasing the tube diameter. The bougie intubation carries the risk of vocal cords injury and impossibility of advancing the tracheal tube if the respiratory space is too narrow.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24152537Norskov AK, Rosenstock CV, Wetterslev J, Lundstrom LH. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. Trials. 2013 Oct 23;14:347. doi: 10.1186/1745-6215-14-347.
Background: PubMed 9349093Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available.

Related trials for Intubation;Difficult

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation

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.

Ioan Florin Marchis, Md principal investigator

University of Medicine and Pharmacy Iuliu Hatieganu- Cluj Napoca, Romania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing classical laryngoscopy and rigid tube for laryngoscopy in people with Intubation;Difficult, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

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 2 inclusion and 3 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 9 Apr 2021. 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 Romania. 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?

Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Tracheal Intubation With the Rigid Tube (time frame: 120 seconds). 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 NCT03341507, 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 9 Apr 2021.