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

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ClinicalTrials.gov Identifier: NCT03929445
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada A.Kamhawy, Suez Canal University

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.

Condition or disease Intervention/treatment Phase
Intubation;Difficult Endotracheal Tube Wrongly Placed During Anesthetic Procedure Device: Endotracheal tube introducers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2017
Actual Study Completion Date : November 2018

Arm Intervention/treatment
Active Comparator: AIR-Q group
the group which selected randomly to try AIR-Q device
Device: Endotracheal 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.

Other Name: The Gum Elastic Bougie

Active Comparator: I-LMA group
the group which selected randomly to try I-LMA device
Device: Endotracheal 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.

Other Name: The Gum Elastic Bougie




Primary Outcome Measures :
  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 ]
    1. 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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03929445


Locations
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Egypt
Ghada A.Kamhawy
Cairo, Egypt, 12311
Sponsors and Collaborators
Suez Canal University
Investigators
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Principal Investigator: Ghada A. Kamhawy, Lecturer Suez Canal University

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Responsible Party: Ghada A.Kamhawy, Clinical professor, Suez Canal University
ClinicalTrials.gov Identifier: NCT03929445     History of Changes
Other Study ID Numbers: Ghada
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ghada A.Kamhawy, Suez Canal University:
Bougie
Air Q
Fastrach