- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850757
Comparison Between Modified William's Airway and U Shaped Guedl's Airway
Comparative Study Between Modified William's Airway (Fekry Airway ) Versus the U Shaped Guedl's Airway as Assessed Device for Fiberoptic Intubation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several oropharyngeal airways and supraglotic devices have been invented to facilitate the art of fiber optic intubation. The oropharyngeal airways help during fiber optic intubation through raising the soft palate and the tongue away from the field of bronchoscope .(1)The modification made to the Williams airway (Fekry's airway) is that the roof of the proximal cylindrical tunnel was removed and opened from its concave part to allow one step insertion of the tube. There is no need for removal of the tube connector or the airway after tube insertion.(3)We invented a new modification in Guedel's airway (The U-shaped Guedel's airway) which is made by making an inverted Y shape cut in the roof of the airway keeping only the proximal Y wings and removing the distal part of the roof.This study will be conducted at Kasr AL-Ainy Hospital Faculty of Medicine Cairo university Egypt , after approval of the ethical committee and taking written informed consents from the patients . Patients presents to the hospital for elective surgery under general anasethia will be randomly divided into 2 groups : Group W (Gw)(n=25 ) the fiber optic intubation will be assisting by modified Williams airway and Group U (Gu)(n=25) the fiber optic intubation will be assisting by U shaped Guedels airway .
In the preparation room 20 guage cannula will be inserted in a peripheral vein . 0,02 mg\ Kg midazolam and 0,01 mg\Kg atropine will be given in the operating room Standard monitors ( ECG, noninvasive Blood pressure and pulse oximetry) will be established to the patient .After 3 minutes preoxygenation with 100% O2 induction was conducted using 1µg\Kg fentanyl,2mg\Kg propofol and 0.05 mg\Kg atracurium. After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion was done according to manufacturer structures . The patient will be ventilated by facemask and bag with 100% oxygen and 1-2% isoflourane. Complete neuromuscular block was confirmed using nerve stimulator (train of four zero).the fiber optic bronchoscope inserted through the airway (modified Williams, U Shaped Guedels airway ) according to the patient group . The time of fiber optic bronchoscope insertion will be recorded in seconds (defined as the time elapsing from the entry of fiber optic bronchoscope through the airway till touching the vocal cords by the tip of bronchoscope) . The investigator will assesse the bronchoscopic view just after the end of the airway . after recording the time of fiberopticbronchoscope insertion the endotracheal tube was slided through vocal cords into the trachea reaching the carina . the patient will be ventilated through the endotracheal tube using intermittent positive pressure ventilation (IPPV) . Endotracheal intubation will be confirmed by chest expansion ,bilateral equal air entry using stethoscope and the appearance 6 successive capnographic waves. Time of intubation will be recorded from stop mask-bag ventilation till reventilate the patient using the endotrachealtube and reading of capnogram. ( the attempt will be cancelled and bag-mask ventilation started if SPO2 reach 93%. )
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient aged above 18 years old.
- Patient that has ASA I,II .
- Patient with Ganzouri airway score less than 4.
Exclusion Criteria:
- Patient aged below 18 years old.
- Patient that has ASA III ,IV.
- Patients at risk of aspiration of gastric content.
- Patient with Ganzouri airway score equal or more than 4.
- Patient that has any anatomical abnormality that invalidate Ganzouri airway score.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: U shaped Guedl's airway
|
To use U shaped Guedl's airway for assisting fiberoptic bronchoscope during endotracheal intubation
|
EXPERIMENTAL: Modified William's airway(Fekry airway )
|
Use Modified William's airway for assisting fiberoptic bronchoscope dduring endo tracheal intubation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of endotracheal intubation
Time Frame: within 15 minutes from induction of general anesthesia
|
within 15 minutes from induction of general anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of fiberopticc bronchscpe reach the vocal cords
Time Frame: within 15 minutes from induction of general anesthesia
|
within 15 minutes from induction of general anesthesia
|
Bronchoscopic view grade
Time Frame: within 15 minutes from induction of general anesthesia
|
within 15 minutes from induction of general anesthesia
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maha My youssef, consultant, Kasr alaini hospital,faculty of medicine,cairo university
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N-18-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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