Bougie Assisted Endotracheal Intubation in Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask

Study Overview
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Brief Summary
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This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.

Detailed Description
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The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails. Study objectives To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals. To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.

Official Title
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A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation

Conditions
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Intubation;Difficult, Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention / Treatment
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* Device: Endotracheal tube introducers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged >18 years old. Gender both male and female. Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations Exclusion Criteria: Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination. Patients with unstable cervical spine Any medical disease that may affect airway as Rheumatoid arthritis. Patient refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AIR-Q group<br>the group which selected randomly to try AIR-Q device | Device: Endotracheal tube introducers<br>* Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use. ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades. The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie.<br>* Other names: The Gum Elastic Bougie;|
| Active Comparator: I-LMA group<br>the group which selected randomly to try I-LMA device | Device: Endotracheal tube introducers<br>* Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use. ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades. The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie.<br>* Other names: The Gum Elastic Bougie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach | If the blind intubation is failed through Air Q or Fastrack Intubating laryngeal mask the investigator will use gum elastic bougie to facilitate introducing an endotracheal tube estimation of success rate of endotracheal intubation on the first, second and third attempts | 180 seconds after anethesia induction | 
| The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask) | Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time). Endotracheal tube (ETT) insertion time will be measured ( ETT time). Total insertion time will be estimated (Device Time + ETT Time ) | !80 seconds after anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of adverse events and complications during and after the procedure will be also recorded. Complications, including laryngospasm, bleeding, false passage, and sore throat will be recorded intraoperatively and in the first 48 postoperative hours. | Intraoperative and in the first 48 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bougie, Air Q, Fastrach