Trial Outcomes & Findings for Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method (NCT NCT03341507)

NCT ID: NCT03341507

Last Updated: 2021-04-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

120 seconds

Results posted on

2021-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Laryngoscopy and Tracheal Intubation 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed if the Cormack -Lehane glottis view is 2b,3 or 4 during conventional laryngoscopy
Overall Study STARTED	64
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Laryngoscopy and Tracheal Intubation 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed if the Cormack -Lehane glottis view is 2b,3 or 4 during conventional laryngoscopy
Overall Study Cormack-Lehane grade 1 or 2a during conventional laryngoscopy	34

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tracheal Intubation With the Rigid Tube for Laryngoscopy n=64 Participants The study involved adult patients with ASA physical status 1-3, requiring surgery for an ENT pathology and having a presumed anatomically difficult airway according to The Simplified Airway Risk Index (SARI) score . Signed informed consent was obtained from all patients.
Age, Continuous	47.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
The Simplified Airway Risk Index Scale(SARI) score ≥ 5.	6 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 120 seconds

Population: 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.

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

Outcome measures

Outcome measures
Measure	Laryngoscopy and Tracheal Intubation n=30 Participants 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Time to Tracheal Intubation With the Rigid Tube	50.5 seconds Interval 38.0 to 67.0

SECONDARY outcome

Timeframe: 5 minutes

complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%

Outcome measures

Outcome measures
Measure	Laryngoscopy and Tracheal Intubation n=30 Participants 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Complications During Intubation With Rigid Tube	1 Participants

SECONDARY outcome

Timeframe: 3 days

complications noticed following the use of rigid tube - sore throat, upper lip injury.

Outcome measures

Outcome measures
Measure	Laryngoscopy and Tracheal Intubation n=30 Participants 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Late Complications of Intubation With Rigid Tube	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 seconds

Population: Conventional laryngoscopy was performed with a MacIntosh curved blade laryngoscope, and the Cormack-Lehane grade of glottis visualization was registered. If the grade of glottis view according to Cormack-Lehane classification was less than 2b the patient was intubated using the curved blade laryngoscope. If the grade of glottis view was equal or more than 2b the tracheal intubation was carried further with the rigid tube.

Conventional laryngoscopy was performed with a MacIntosh curved blade laryngoscope, and the Cormack-Lehane grade of glottic visualization was registered. If the grade of glottis view according to Cormack-Lehane classification was less than 2b the patient was intubated using the curved blade laryngoscope. If the grade of glottic view was equal or more than 2b the tracheal intubation was carried further with the rigid tube.

Outcome measures

Outcome measures
Measure	Laryngoscopy and Tracheal Intubation n=64 Participants 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. classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
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.	34 Participants

Adverse Events

Laryngoscopy and Tracheal Intubation

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Laryngoscopy and Tracheal Intubation n=64 participants at risk 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. classical laryngoscopy: the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Respiratory, thoracic and mediastinal disorders hypoxia	1.6% 1/64 • Number of events 1 • complications noticed during and following the use of rigid tube : time frame-3 days Complications during intervention- hypoxia, cardiac rhythm disturbances, hypertension, cardiac arrest, bronchospasm. Patient assessment after anesthesia for sore throat, voice disturbances, bleeding, teeth and soft tissue injury, neurological disorders following intervention, coughing, shortness of breath or chest pain

Other adverse events

Other adverse events
Measure	Laryngoscopy and Tracheal Intubation n=64 participants at risk 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. classical laryngoscopy: the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Respiratory, thoracic and mediastinal disorders sore throat	16.7% 5/30 • Number of events 5 • complications noticed during and following the use of rigid tube : time frame-3 days Complications during intervention- hypoxia, cardiac rhythm disturbances, hypertension, cardiac arrest, bronchospasm. Patient assessment after anesthesia for sore throat, voice disturbances, bleeding, teeth and soft tissue injury, neurological disorders following intervention, coughing, shortness of breath or chest pain
Skin and subcutaneous tissue disorders upper lip injury	10.0% 3/30 • Number of events 3 • complications noticed during and following the use of rigid tube : time frame-3 days Complications during intervention- hypoxia, cardiac rhythm disturbances, hypertension, cardiac arrest, bronchospasm. Patient assessment after anesthesia for sore throat, voice disturbances, bleeding, teeth and soft tissue injury, neurological disorders following intervention, coughing, shortness of breath or chest pain

Additional Information

Dr Ioan Florin Marchis

Iuliu Hatieganu University of Medicine and Pharmacy- Cluj Napoca Romania

Phone: +40757065205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place