Oral Surgery Clinical Trial
— VIDiACOfficial title:
Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery
NCT number | NCT03950934 |
Other study ID # | PV5856 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | May 1, 2020 |
Verified date | May 2020 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.
Status | Completed |
Enrollment | 400 |
Est. completion date | May 1, 2020 |
Est. primary completion date | April 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - 18 Years and older - Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation - Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation Exclusion criteria: - No consent given - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difficult videolaryngoscopic intubation | Questionnaire | 30 minutes after endotracheal intubation | |
Secondary | Successful first intubation attempt | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Overall success | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Unsuccessful videolaryngoscopy | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Severity of videolaryngoscopic intubation | Numeral rating scale | 30 minutes after endotracheal intubation | |
Secondary | Specific recommendations of the handling anesthetist | Questionnaire | 30 minutes after endotracheal intubation | |
Secondary | Time to successful intubation | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Number of laryngoscopy and intubation attempts | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Lowest oxygen saturation during airway management | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Initial end-tidal carbon dioxide level after successful intubation | Observation during airway management | 30 minutes after endotracheal intubation | |
Secondary | Observed complications during or after induction of general anesthesia | Questionnaire | 30 minutes after endotracheal intubation | |
Secondary | Length of hospital stay | Follow-up | Until hospital discharge up to 3 months after surgery | |
Secondary | All cause in-hospital mortality | Follow-up | Until hospital discharge up to 3 months after surgery |
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