Evaluation of Truflex™ Flexible Stylet as an intubation guide with the D-blade of C-Mac videolaryngoScope during elective tracheal intubation

Assessment of Truflex™ Flexible Stylet versus conventional rigid Portex™ stylet as an intubation guide with the D-blade of C-Mac videolaryngoScope during elective tracheal intubation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57679531

Enrollment

154

Registered

2013-02-12

Start date

2013-03-15

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing elective surgical procedure under general anesthesia needing tracheal intubation Surgery Tracheal intubation

Interventions

Endotracheal Intubation with C-Mac?s D- blade videolaryngoscope by an experienced anesthesiologist using either of the following two intubation guides. Study Group A: A well lubricate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient has been informed of the investigational nature of this study and has given verbal informed consent in accordance with Hospital Ethical Committee guidelines. 2. Males or females = 18 - 60 years of age 3. American Society of Anesthesiologist?s grade I and II patients 4. Elective surgical procedure under general anesthesia needing tracheal intubation

Exclusion criteria

Exclusion criteria: 1. Pregnant female 2. Known allergies to either study devices or its components 3. Known bleeding/coagulation disorder 4. Immobilized cervical spine 5. Any pathologies of the mouth, pharynx or larynx 6. Previous ENT surgeries 7. Known malignancies prior to randomisation 8. Chronic kidney disease, chronic liver disease or heart failure

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 24/09/2013: 1. Successful or failed intubation at the first attempt 2. Total Intubation Time - This shall include: 2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view) 2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord. 3. Intubation Difficulty Score Previous primary outcome measures: 1. Successful or failed tracheal intubation 2. Total Intubation Time - This shall include: 2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view) 2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord. 3. Intubation Difficulty Score	—

Measure

Time frame

Current primary outcome measures as of 24/09/2013: 1. Successful or failed intubation at the first attempt 2. Total Intubation Time - This shall include: 2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view) 2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord. 3. Intubation Difficulty Score Previous primary outcome measures: 1. Successful or failed tracheal intubation 2. Total Intubation Time - This shall include: 2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view) 2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord. 3. Intubation Difficulty Score

—

Secondary

Measure	Time frame
1. Intubation attempts - maximum three attempts, after which the technique will be considered as failure. An attempt shall be counted if the laryngoscope or the ETT needs to be removed for re-oxygenation (drop in oxygen saturation by 5%) or for reshaping of the ETT. 2. Glotticoscopy time & ETT negotiation time as described in primary outcome measure above 3. Overall user satisfaction (Scale 1-10): 1-3=Poor, 4-6=Fair, 7-10=Good) 4. Cormack & Lehanne?s grading	—

Measure

Time frame

1. Intubation attempts - maximum three attempts, after which the technique will be considered as failure. An attempt shall be counted if the laryngoscope or the ETT needs to be removed for re-oxygenation (drop in oxygen saturation by 5%) or for reshaping of the ETT. 2. Glotticoscopy time & ETT negotiation time as described in primary outcome measure above 3. Overall user satisfaction (Scale 1-10): 1-3=Poor, 4-6=Fair, 7-10=Good) 4. Cormack & Lehanne?s grading

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Countries

Oman

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026