Back to resultsComparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask
Primary Purpose
Airway Management, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Air-Q intubating laryngeal airway
Ambu-Aura intubating laryngeal mask
Sponsored by
About this trial
This is an interventional treatment trial for Airway Management focused on measuring obesity, Air QTM intubating airway, Ambu-Aura intubating laryngeal mask
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-65 years old.
- Sex: both genders.
- With American society of anaesthesiologists (ASA) physical activity II.
- Scheduled for elective surgery under general anaesthesia requiring endotracheal tube.
- Class II obese patients (BMI 34.9 - 39.9 kg/m2).
- Surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery.
Exclusion Criteria:
• Patient refusal.
- Patients with any respiratory tract abnormalities as laryngeal masses & facial deformities as fracture mandible.
- Patients with risk of pulmonary aspiration as in full stomach patients.
- Patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (GERD) and pregnant females.
- Emergency operation.
- Patients with obstructive sleep apnea.
- Patients prepared for laparotomy or laparoscopic procedures.
- Patients with risk of bleeding.
Sites / Locations
- Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Air-Q intubating laryngeal airway mask
Ambu-Aura intubating laryngeal mask
Arm Description
Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope. After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Air-Q will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2were recorded 5 minutes after device insertion. Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope. After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Ambu-Aura laryngeal mask will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2 will be recorded 5 minutes after device insertion. Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Outcomes
Primary Outcome Measures
airway seal pressure
Measuring the seal pressure above which the oropharyngeal leak through the supraglottic device will occur (1 minute after confirmation of successful insertion).
Secondary Outcome Measures
Success rate
Success rate of device insertion
arterial blood pressure
systolic and diastolic arterial blood pressure. • Stress response related to the device used.
heart rate
• Stress response related to the device used
Laryngeal view grade.
Grade 1: only larynx was seen, Grade 2: larynx plus the posterior surface of epiglottis were seen. Grade 3: larynx and anterior tip of epiglottis were seen with <50% visual obstruction of larynx.
Grade 4: epiglottis down folded and its anterior surface were seen with >50% visual field obstruction.
Grade 5: complete down folding of epiglottis and the larynx could not be seen directly
Success rate of intubation by fiberoptic bronchoscope
The success of the ventilation will be determined based on visible chest expansion, adequate tidal volume and drawing of 6 successive ETCO2 waves.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04195035
Brief Title
Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask
Official Title
Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Anticipated)
Study Completion Date
January 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Supraglottic airway devices are important tools for airway management. Supraglottic airway devices have been introduced into brief surgical interventions because they are less invasive than intubation and safer than mask to maintain the patency of airway after induction of anesthesia. They are inserted via the oral route and can be used in emergency conditions when tracheal intubation and mask anesthesia are challenging.
Air Q intubating airway and Ambu Aura intubating laryngeal mask are two Supraglottic airway devices that are widely used.
Aim of the work is to compare Air-Q intubating laryngeal airway versus Ambu-Aura intubating laryngeal mask regarding sealing pressure and Fiberoptic intubation in class II obese patients.
Detailed Description
Randomized comparative trial that will be performed in Kasr Al Ainy hospital, Cairo University, Cairo, Egypt.ASA II patients from 20 to 50 years of age, undergoing minor surgry were included in this study. 40 patients will be allocated into 2 equal groups using computerized software and enclosed in sealed opaque envelopes:
GQ ( n=20 ): Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
GA ( n=20 ): Where Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Management, Obesity
Keywords
obesity, Air QTM intubating airway, Ambu-Aura intubating laryngeal mask
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air-Q intubating laryngeal airway mask
Arm Type
Experimental
Arm Description
Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Air-Q will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2were recorded 5 minutes after device insertion.
Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Arm Title
Ambu-Aura intubating laryngeal mask
Arm Type
Experimental
Arm Description
Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.
After complete muscle relaxation a suitable sized (according to the patient's weight and BMI) Ambu-Aura laryngeal mask will be lubricated inserted and the ventilator circuit will be connected to the device to ventilate the patient. The ventilator will be set with tidal volume 4-6 ml/kg at a respiratory rate 12-15 breath/minute to keep normocapnia (ETCO2=30-35 mmHg). Vitals (HR, ABP and O2 saturation) and ET CO2 will be recorded 5 minutes after device insertion.
Then intubation using the fiberoptic bronchoscope will be started through the supraglottic device, laryngeal view grade will be recorded, success of endotracheal intubation through the device and time of intubation (time starting from disconnection of the circuit from the device to use the fiberoptic brochoscope for intubation till tube insertion in the trachea).
Intervention Type
Device
Intervention Name(s)
Air-Q intubating laryngeal airway
Intervention Description
Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
Intervention Type
Device
Intervention Name(s)
Ambu-Aura intubating laryngeal mask
Intervention Description
Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.
Primary Outcome Measure Information:
Title
airway seal pressure
Description
Measuring the seal pressure above which the oropharyngeal leak through the supraglottic device will occur (1 minute after confirmation of successful insertion).
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Success rate
Description
Success rate of device insertion
Time Frame
1 minute
Title
arterial blood pressure
Description
systolic and diastolic arterial blood pressure. • Stress response related to the device used.
Time Frame
2 hours
Title
heart rate
Description
• Stress response related to the device used
Time Frame
2 hours
Title
Laryngeal view grade.
Description
Grade 1: only larynx was seen, Grade 2: larynx plus the posterior surface of epiglottis were seen. Grade 3: larynx and anterior tip of epiglottis were seen with <50% visual obstruction of larynx.
Grade 4: epiglottis down folded and its anterior surface were seen with >50% visual field obstruction.
Grade 5: complete down folding of epiglottis and the larynx could not be seen directly
Time Frame
1 minute
Title
Success rate of intubation by fiberoptic bronchoscope
Description
The success of the ventilation will be determined based on visible chest expansion, adequate tidal volume and drawing of 6 successive ETCO2 waves.
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-65 years old.
Sex: both genders.
With American society of anaesthesiologists (ASA) physical activity II.
Scheduled for elective surgery under general anaesthesia requiring endotracheal tube.
Class II obese patients (BMI 34.9 - 39.9 kg/m2).
Surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery.
Exclusion Criteria:
• Patient refusal.
Patients with any respiratory tract abnormalities as laryngeal masses & facial deformities as fracture mandible.
Patients with risk of pulmonary aspiration as in full stomach patients.
Patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (GERD) and pregnant females.
Emergency operation.
Patients with obstructive sleep apnea.
Patients prepared for laparotomy or laparoscopic procedures.
Patients with risk of bleeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Inas Farouk
Email
inasfarouk@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25559870
Citation
Kim MS, Lee JH, Han SW, Im YJ, Kang HJ, Lee JR. A randomized comparison of the i-gel with the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2015 Apr;25(4):405-12. doi: 10.1111/pan.12609. Epub 2015 Jan 6.
Results Reference
background
PubMed Identifier
21081777
Citation
Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
Results Reference
background
PubMed Identifier
27847515
Citation
Yahaya Z, Teoh WH, Dintan NA, Agrawal R. The AMBU(R) Aura-i Laryngeal Mask and LMA Supreme: A Randomized Trial of Clinical Performance and Fibreoptic Positioning in Unparalysed, Anaesthetised Patients by Novices. Anesthesiol Res Pract. 2016;2016:4717061. doi: 10.1155/2016/4717061. Epub 2016 Oct 25.
Results Reference
background
PubMed Identifier
21880031
Citation
Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.
Results Reference
background
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Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask
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