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

NCT03341507 | Completed Results

• 1 other identifier: MIFlorin
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation;Difficult

Keywords

laryngoscopy; retromolar

Outcome Measures

Primary Outcomes (1)

• Time to Tracheal Intubation With the Rigid Tube

  the time from starting to use the rigid tube for laryngoscopy until the airway was secured.

  120 seconds

Secondary Outcomes (2)

• Complications During Intubation With Rigid Tube

  5 minutes

• Late Complications of Intubation With Rigid Tube

  3 days

Other Outcomes (1)

• Conventional Laryngoscopy With the Curved Blade Laryngoscope ( MacIntosh) and Tracheal Intubation With the Curved Blade Laryngoscope if the Cormack-Lehane Glottis View Grade is 1 or 2a.

  60 seconds

Study Arms (1)

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.

Device: classical laryngoscopy; Device: rigid tube for laryngoscopy

Interventions

classical laryngoscopy DEVICE

the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.

Also known as: laryngoscopy with McIntosh curved blade laryngoscope

laryngoscopy and tracheal intubation

rigid tube for laryngoscopy DEVICE

the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed

laryngoscopy and tracheal intubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Cluj County Emergency Hospital- ENT Clinic

Cluj-Napoca, Cluj, 400006, Romania

Location

Related Publications (2)

• 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.

  PMID: 24152537 BACKGROUND

• Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available.

  PMID: 9349093 BACKGROUND

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Ioan Florin Marchis
• Organization: Iuliu Hatieganu University of Medicine and Pharmacy- Cluj Napoca Romania

marchis.ioan@umfcluj.ro

+40757065205

Study Officials

• Ioan Florin Marchis, Md

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 14, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 7, 2019
• Last Updated: April 9, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-03

Locations

RO (1)