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Completed

NCT Number: NCT01906060

Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial

The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%.

Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%.

This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA.

* Trial with medical device

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Key information

Conditions

Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Lodz, Lodz, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective surgery requiring tracheal intubation using an oral tracheal tube
  • anticipated extubation in the operating room
  • American Society of Anaesthesiologist Physical Status 1-3
  • age = 18 years and = 85 years
  • oral and written informed consent
  • weight = 100kg (according to the product description)
  • ability to understand the study information

Exclusion criteria

  • pharyngeal, laryngeal or tracheal pathology, including tracheostomy
  • mouth opening < 2.5 cm
  • any form of airway infection such as upper-respiratory tract infection, pneumonia or suspected tuberculosis
  • any disease that might impair the power of judgement (psychiatric disease, dementia)
  • indicated rapid sequence induction which is a standard when high risk for regurgitation and/or aspiration is present
  • the subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
  • pregnancy
  • breast feeding

Treatment and study plan

Air-Q Intubation Laryngeal Mask

Device

Patients will be intubated using the Air-Q Laryngeal Mask.

Primary outcomes

  1. Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.

    Time frame: 300 seconds

    Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts.

Secondary outcomes

  1. Time for insertion of the Air-Q laryngeal mask

    Time frame: 300 seconds

    defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform

  2. Time for insertion of the tube

    Time frame: 300 seconds

    defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform

  3. First attempt rate and second attempt rate

    Time frame: 300 seconds

  4. Time for removal of the Air-Q ILA device after successful intubation

    Time frame: 500 seconds

  5. Rate of misplacement of the ILA

    Time frame: 300 seconds

  6. Rate of misplacement of the tube

    Time frame: 500 seconds

  7. risk factors of insertion failures

    Time frame: 500 seconds

  8. Rate of airway injuries

    Time frame: 5 hours

  9. Tightness during leak test before relaxation

    Time frame: 300 seconds

  10. Tightness during leak test after relaxation

    Time frame: 300 seconds

  11. Maximum drop of saturation during airway management

    Time frame: 500 seconds

  12. Rate of adverse events

    Time frame: 5 hours

    including, but not limited to suspicion of aspiration or regurgitation (gastric fluid in the ventilation tube or hypopharynx), bronchospasm, airway obstruction, coughing, dental-, tongue-, lip- pharyngeal or laryngeal trauma

  13. Rate of necessity of alternative airway device

    Time frame: 500 seconds

  14. Rate of blood stained devices after removal of the ILA

    Time frame: 500 seconds

  15. Postoperative coughing after 2 hours and the next morning

    Time frame: 24 hours

  16. Postoperative hoarseness after 2 hours and the next morning

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2013
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.