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Airway ManagementNCT04195035

Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask

A study testing Air-Q intubating laryngeal airway and Ambu-Aura intubating laryngeal mask in people with Airway Management and Obesity, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Airway Management, Obesity
What is being tested?
Air-Q intubating laryngeal airway and Ambu-Aura intubating laryngeal mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
10 Dec 2019to 15 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Bassant abdelhamid contact

01224254012

bassantmohamed197@yahoo.com

Inas Farouk contact

inasfarouk@hotmail.com

Egypt1 site, 1 recruiting

  • Cairo university

    Cairo, 1772

    Bassant abdelhamid, 01224254012, bassantmohamed197@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.

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.

Read the 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.

Being tested
Air-Q intubating laryngeal airway, Ambu-Aura intubating laryngeal mask
Keywords
obesity, Air QTM intubating airway, Ambu-Aura intubating laryngeal mask
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Air-Q intubating laryngeal airwayDevice

    Air-Q intubating laryngeal airway will be used for ventilation \& intubation through fiberoptic bronchoscope.

  • Ambu-Aura intubating laryngeal maskDevice

    Ambu-Aura intubating laryngeal mask will be used for ventilation \& intubation through fiberoptic bronchscope.

Study groups in NCT04195035
Study groupRoleWhat they receive
Air-Q intubating laryngeal airway maskExperimentalWhere 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).
Receives: Device: Air-Q intubating laryngeal airway
Ambu-Aura intubating laryngeal maskExperimentalAmbu-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).
Receives: Device: Ambu-Aura intubating laryngeal mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 minute

Secondary outcomes (5)

  1. Success rate

    Success rate of device insertion

    Measured: 1 minute

  2. arterial blood pressure

    systolic and diastolic arterial blood pressure. • Stress response related to the device used.

    Measured: 2 hours

  3. heart rate

    • Stress response related to the device used

    Measured: 2 hours

  4. 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

    Measured: 1 minute

  5. 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.

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2019
  2. Study start10 Dec 2019
  3. Primary completion10 Jan 2020 (estimated)
  4. Study completion15 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04195035
Sponsor's protocol ID
S-19-2019
Status last verified
Dec 2019
First submitted
7 Dec 2019
Last updated
19 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25559870

  • 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.

    PubMed 21081777

  • 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.

    PubMed 27847515

  • 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.

    PubMed 21880031

Questions about this trial

What is this clinical trial studying?

A study testing Air-Q intubating laryngeal airway and Ambu-Aura intubating laryngeal mask in people with Airway Management and Obesity, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bassant abdelhamid (01224254012, bassantmohamed197@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

airway seal pressure (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04195035, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.

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