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Completed

NCT Number: NCT03929445

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

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.

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Key information

Conditions

Intubation;Difficult Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghada A.Kamhawy

Cairo, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Endotracheal tube introducers

Device

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.

Other names: The Gum Elastic Bougie

Primary outcomes

  1. success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach

    Time frame: 180 seconds after anethesia induction

    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

  2. The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)

    Time frame: !80 seconds after anesthesia induction

    • 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 )

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Intraoperative and in the first 48 postoperative hours

    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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 26, 2019
Registry last updated
Apr 30, 2019

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.

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