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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453683
Other study ID # Intubation in morbid obese
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date June 20, 2020

Study information

Verified date January 2023
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare air Q versus ILMA intubation in obese adult paralyzed patient


Description:

Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 20, 2020
Est. primary completion date June 20, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:All morbidly obese patient defined as BMI >40 kg/m2 scheduled for an elective surgery requiring general anesthesia with tracheal intubation were enrolled on the day of their surgery. ASA physical status (I-II) Exclusion Criteria physical status of IV or V or had a history of impossible tracheal intubation or awake fibreoptic intubation or if preoperative evaluation showed limited mouth aperture <3.5 cm or showed evidence that an awake fiberoptic intubation or rapid sequence induction would be required patients at increased risk for aspiration of gastric contents, coagulopathy or those with unstable cervical spines or requiring nasal route for tracheal intubation -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Air-Q. ILA insertion of proper size
Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
ILMA insertion of proper size
Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device

Locations

Country Name City State
Egypt Zagazig University Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C. — View Citation

Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary success rate of tracheal intubation through each device. success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
Secondary Insertion time of supraglottic airway devices Time necessary for insertion was measured from the time the face mask was taken away until the appearance of Co2 on the capnograph while supraglottic airway device in place It is about 13-19 second for insertion of supraglottic airway devices
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