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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05522049
Other study ID # 2022-100868-BO-ff
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date July 31, 2023

Study information

Verified date September 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery - Expected difficult intubation - Age = 18 Exclusion Criteria: - Pregnant or breastfeeding woman - Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents) - Required transnasal tracheal intubation (e.g. for surgical reasons) - Special tubes required for surgical reasons ( e.g. double lumen tube) - Denial of consent

Study Design


Intervention

Device:
hyperangulated videolaryngoscope
Intubation using a hyperangulated videolaryngoscope
Macintosh videolaryngoscope
Intubation using a Macintosh videolaryngoscope

Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of glottic opening (POGO) Grading of the best view obtained during laryngoscopy (%) 1 hour
Secondary Time to successful tracheal intubation (seconds) Recorded during airway management 1 hour
Secondary Time to successful first attempt intubation (seconds) Recorded during airway management 1 hour
Secondary Cormack-Lehane grade Grading of the best view obtained during laryngoscopy (I [best] to IV [worst]) 1 hour
Secondary Impaired view (vocal cords cannot be visualized by laryngoscopy) Number of participants with impaired view observed during airway management 1 hour
Secondary Difficult laryngoscopy Number of participants with difficult laryngoscopy as defined in current guidelines 1 hour
Secondary Difficult intubation Number of participants with difficult tracheal intubation as defined in current guidelines 1 hour
Secondary Transition to a different tracheal intubation technique Number of participants in whom the airway operator decided to convert to an alternative intubation technique 1 hour
Secondary Tracheal introducer Number of participants in whom the airway operator decided to use a tracheal introducer 1 hour
Secondary Successful first attempt Number of participants with successful tracheal intubation with only one attempt 1 hour
Secondary Overall success of intubation Number of participants with successful tracheal intubation regardless of the the number of attempts 1 hour
Secondary Difficulty of videolaryngoscope-guided intubation VIDIAC (Videolaryngoscopic Intubation and Difficult Airway Classification) Score from -1 (best) to 5 (worst) 1 hour
Secondary Number of intubation attempts Observed during airway management 1 hour
Secondary Number of laryngoscopy attempts Observed during airway management 1 hour
Secondary Airway related adverse events Number of participants with airway related adverse events observed during airway management 1 hour
Secondary Hypoxaemia Number of participants with a drop in peripheral oxygen saturation during airway management 1 hour
Secondary Hypotension Number of participants with hypotension observed during airway management 1 hour
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