An interventional study of Tracheal intubation in Intubation, sponsored by Northern Health and Social Care Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2010-11-15.
Sponsored by Northern Health and Social Care Trust · Not applicable, Interventional, and Treatment
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.
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.
Northern Health and Social Care Trust is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: intubation, insertion of tracheal tube
Success rate of tracheal intubation (%)
Time frame: After successful insertion of tracheal tube
Time needed for successful insertion of a supraglottic device
Time frame: After insertion
Total time needed for successful tracheal intubation through a device
Time frame: After insertion
Fibreoptic view following to supraglottic device insertion
Time frame: After insertion of SGA
Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea
Time frame: at 1 h after operation, at 24 h
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Northern Health and Social Care Trust