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Airway Management in Morbidly Obese Patients: A Comparison Between Fiber Optic-guided Intubating Laryngeal Mask and Air Q

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04453683
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Air-Q. ILA insertion of proper size
  • Device: ILMA insertion of proper size
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Airway Management in Morbidly Obese Patients: A Comparison Between Intubating Laryngeal Mask and Air Q in Conjunction With Fiberoptic Bronchoscopy
Actual Study Start Date :
Jun 20, 2019
Actual Primary Completion Date :
Jun 20, 2020
Actual Study Completion Date :
Jun 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I ( Air Q)

nsertion of proper size Air-Q. ILA

Device: Air-Q. ILA insertion of proper size
Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
Active Comparator: Group II (ILMA)

nsertion of proper size ILMA

Device: ILMA insertion of proper size
Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device

Outcome Measures

Primary Outcome Measures

  1. success rate of tracheal intubation through each device. [Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices]

    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

Secondary Outcome Measures

  1. Insertion time of supraglottic airway devices [It is about 13-19 second for insertion 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

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Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig University Zagazig Egypt 002055

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Principal Investigator: Heba M EL-Asser, MD, Zagazig University
  • Principal Investigator: Heba M Heba, MD, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Heba Mohamed EL -Asser,MD, principal investigator, Zagazig University
ClinicalTrials.gov Identifier:
NCT04453683
Other Study ID Numbers:
  • Intubation in morbid obese
First Posted:
Jul 1, 2020
Last Update Posted:
Jul 1, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 1, 2020