Ambu Aura-i Laryngeal Mask Versus Air-Q Intubating Laryngeal Airway for Tracheal Intubation in Adults

NCT ID: NCT02226211

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

Brief Summary

Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice. they can be used as primary airway devices or as conduits for endoracheal intubation and they become an integral part in the recent guidelines for managing difficult airway.

Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal intubation.

The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage over the competitors but not will studied as a conduit for endoracheal intubation.

This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.

Conditions

Failed or Difficult Intubation (Anaesthesia Complications)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

air-Q group

Group Type: EXPERIMENTAL

Air-Q intubation laryngeal airway

Intervention Type: DEVICE

The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.

After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.

After successful intubation, the device will be removed according to the manufactures guides using removal stylet .

aura-i group

Group Type: EXPERIMENTAL

Ambu-Aura i laryngeal mask

Intervention Type: DEVICE

The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (> 100kg).

After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.

After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.

After successful intubation, the device will be removed according to the manufactures guides using another ETT.

Interventions

Air-Q intubation laryngeal airway

The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.

After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.

After successful intubation, the device will be removed according to the manufactures guides using removal stylet .

Intervention Type: DEVICE

Ambu-Aura i laryngeal mask

The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (> 100kg).

After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.

After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.

After successful intubation, the device will be removed according to the manufactures guides using another ETT.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients aged from 18-60 years old, ASA I and II and scheduled for elective surgery under general anesthesia

Exclusion Criteria

• history of cardiopulmonary disease, gastro-esophageal reflux disease, abnormal airway anatomy, body mass index > 30 kg.m-2, surgical procedures including head and neck or performed in position other than supine or lithotomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Ahmed, MD

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of Medicine - Cairo university

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abeer Ahmed, lecturer

Role: CONTACT

abeer_ahmed@kasralainy.edu.eg

Facility Contacts

Abeer Ahmed, lecturer

Role: primary

abeer_ahmed@kasralainy.edu.eg

Other Identifiers

N-46-2014

Identifier Type: -

Identifier Source: org_study_id