To intubate patients with a difficult airway in a safe way, so that there is less trauma for the patients compared with classic direct laryngoscopy and intubation.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patiënten die een chirurgische ingreep ondergaan onder narcose met een endotracheale intubatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful insertion of an endotracheal tube in the trachea using a laryngeal
mask as intubation conduit.
Effective airway time
Secondary outcome
number of intubation attempts
verification of correct position endotracheal tube (via fibreoptic scope)
measurement of gastric content (via nasogastric tube drain)
At the time of removal of the laryngeal mask, the presence of blood, gastric
content and/or pathology is noted, including any mouth, lip or tongue injury.
Patients are assessed in the recovery room 2 h after surgery by an observer,
instructed in airway morbidity scoring (sore throat/hoarseness, dysphagia,
dysphonia), and symptoms are graded by the patient from 0 (no) till 3 (severe).
Background summary
This study test the hypothesis that patients with a difficult airway can be
intubated easily by inserting first a laryngeal mask, followed by the
introduction of a fiberscope, in order to visualize the vocal cords. Once the
latter are visualised the endotracheal tube is railroaded into position (in
between the vocal cords into the trachea). The laryngeal mask is subsequentely
removed and the surgical intervention can start as usual.
Study objective
To intubate patients with a difficult airway in a safe way, so that there is
less trauma for the patients compared with classic direct laryngoscopy and
intubation.
Study design
Feasibility study
Intervention
Insertion of a laryngeal mask in stead of direct laryngoscopy and intubation.
Via the laryngeal mask a fiberscope is inserted to visualise the vocal cords.
Once the vocal cords are visualized the endotracheal tube is railroaded into
position (in the trachea).
Study burden and risks
Less risk for damage to teeth and mouth than a classic direct intubation.
Michelangelolaan 2
5623EJ
NL
Michelangelolaan 2
5623EJ
NL
Listed location countries
Age
Inclusion criteria
patients who will undergo general surgery and anaesthesia, for which endotracheal intubation is essential
Exclusion criteria
age < 18 yrs
COPD patients
non-elective patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35533.060.11 |