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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03929445
Enrollment
62
Registered
2019-04-26
Start date
2017-01-31
Completion date
2018-11-30
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Intubation;Difficult

Keywords

Bougie, Air Q, Fastrach

Brief summary

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

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.

Interventions

DEVICEEndotracheal tube introducers

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.

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach180 seconds after anethesia inductionIf 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
The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)!80 seconds after anesthesia induction1. Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time). 2. Endotracheal tube (ETT) insertion time will be measured ( ETT time). 3. Total insertion time will be estimated (Device Time + ETT Time )

Secondary

MeasureTime frameDescription
Incidence of adverse eventsIntraoperative and in the first 48 postoperative hoursIncidence 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026