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Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation

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ClinicalTrials.gov Identifier: NCT00983229
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
Northern Health and Social Care Trust

Brief Summary:

Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines).

The investigators aim to compare three different types of supraglottic device as a conduit for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and I-gel supraglottic airway. Null hypothesis for this study is that all three devices will perform without statistical difference in the means of success rate and time needed for their insertion and tracheal intubation.


Condition or disease Intervention/treatment Phase
Intubation Procedure: Tracheal intubation Not Applicable

Detailed Description:

Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases and can provide an emergency airway in cases of unexpected difficult airway.

The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult airway. Since its development in 1997, it has been used for both blind and fibrescope-guided tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold standard' in supraglottic airways used for tracheal intubation.

The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with its wide bore allows direct passage of a tracheal tube.

The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It has special optical fibres built-in inside its bowl and a liquid crystal display which allows views of the larynx while the endotracheal tube is being placed.

With reference to these supraglottic airway devices, only a small number of case reports detail tracheal intubation through an I-gel in patients with difficult airways. There have been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of CTrach in patients with predicted difficult airways- but no studies comparing the performance of these devices in clinical practice.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Position of Supraglottic Airway as a Conduit for Tracheal Intubation - A Comparison of CTrach, Intubating LMA and I-gel Supraglottic Airway
Study Start Date : August 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: CTrach
  1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
  2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
  3. Insertion of CTrach (sizes 3,4 or 5), establishment of ventilation.
  4. Direct evaluation of laryngeal view through CTrach
  5. Tracheal intubation through CTrach LMA
  6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
  7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.
Procedure: Tracheal intubation
Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
Other Names:
  • intubation
  • insertion of tracheal tube

Active Comparator: Intubating Laryngeal Mask Airway (ILMA)
  1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
  2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
  3. Insertion of ILMA (sizes 3,4 or 5), establishment of ventilation.
  4. Evaluation of laryngeal view through ILMA using fibrescope
  5. Tracheal intubation through ILMA using fibrescope.
  6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
  7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.
Procedure: Tracheal intubation
Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
Other Names:
  • intubation
  • insertion of tracheal tube

Active Comparator: I-gel
  1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
  2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
  3. Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation.
  4. Evaluation of laryngeal view through I-gel using fibrescope
  5. Tracheal intubation through I-gel using fibrescope
  6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
  7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.
Procedure: Tracheal intubation
Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
Other Names:
  • intubation
  • insertion of tracheal tube




Primary Outcome Measures :
  1. Success rate of tracheal intubation (%) [ Time Frame: After successful insertion of tracheal tube ]

Secondary Outcome Measures :
  1. Time needed for successful insertion of a supraglottic device [ Time Frame: After insertion ]
  2. Total time needed for successful tracheal intubation through a device [ Time Frame: After insertion ]
  3. Fibreoptic view following to supraglottic device insertion [ Time Frame: After insertion of SGA ]
  4. Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea [ Time Frame: at 1 h after operation, at 24 h ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III patients
  • Age 18-89 years, males and females
  • Elective surgical patients needing tracheal intubation

Exclusion Criteria:

  • ASA IV or V patients
  • Emergency surgical procedures
  • Patients at increased risk of aspiration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983229


Locations
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United Kingdom
Antrim Area Hospital
Antrim, United Kingdom, BT41 2RL
Sponsors and Collaborators
Northern Health and Social Care Trust
Investigators
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Principal Investigator: Pavel Michalek, MD,PhD,DESA Northern HSC Trust
Publications:

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Responsible Party: Pavel Michalek, MD PhD DESA, Consultant Anaesthetist, Northern Health and Social Care Trust, Antrim Area Hospital
ClinicalTrials.gov Identifier: NCT00983229    
Other Study ID Numbers: 09/NIR03/44
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: October 2010
Keywords provided by Northern Health and Social Care Trust:
difficult airway
fibreoptic intubation
supraglottic airways
laryngeal mask airway