Blind Tracheal Intubation Through Supraglottic Airway Devices

NCT05624073 | Unknown DMC

• 1 other identifier: EH-2022
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation \&ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.

Conditions

Respiration and the Airways With Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• Total insertion time (seconds)

  Total insertion time (seconds): insertion time (seconds) of the SAD is the time needed for correct SAD placement \&started when SAD touched teeth to the first recorded rectangular capnogram curve with satisfactory bilateral chest expansion + insertion time of the endotracheal tube through the SAD (seconds) is the time in seconds from insertion of the endotracheal tube blindly until capnographic confirmation.

  200 seconds

Study Arms (2)

Air-QTM Blocker

GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.

Device: LarySealTM Pro

LarySealTM Pro Laryngeal Mask

GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation.

Device: Air-QTM Blocker

Interventions

Air-QTM Blocker DEVICE

The Air-QTM Blocker (Cookgas LLC, Mercury Medical, Clearwater, FL, USA) is a SAD that is intended for use as a primary airway seal and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. Its design includes a large airway tube inner diameter, a short airway tube length, and a tethered, removable standard 15mm circuit adapter. These features enable direct insertion of larger tracheal tubes up to 7.5 and 8.5mm inner diameters for Air-Q sizes 3.5 and 4.5 respectively (according to body weight; size 3.5: 50-70Kg, size 4.5:70-100Kg). In addition to the soft blocker channel (guide tube) that acts as a conduit for placing medical devices such as NG (Nasogastric) or Blocker tubes. NG tubes are used to decompress and suction the stomach. Standard NG tubes up to 18 Fr. are suitable for all Air-Q Blocker sizes

LarySealTM Pro Laryngeal Mask

LarySealTM Pro DEVICE

The LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in: sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. Both devices accommodated standard conventional endotracheal tubes for intubation.

Air-QTM Blocker

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Eligible subjects of both sexes will be consecutively enrolled and randomly allocated to LarysealTM Pro group or Air-QTM Blocker group through an online randomization program (http://www.randomizer.org) with an allocation ratio of 1:1. GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation. GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.

You may qualify if:

• Age: 18-55 years old.
• ASA I\&II.
• Both sexes.
• El-Ganzouri Airway Score \< or =2

You may not qualify if:

• History of upper respiratory tract infections.
• History of obstructive sleep apnea (OSA) or STOP Bang-Score \> 4.
• Potentially full stomach (trauma, morbid obesity BMI\> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
• Esophageal reflux (hiatus hernia).
• Coagulation disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

RECRUITING

Reham Ali Abdelhaleem Abdelrahman

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reham Ali Abdelhaleem Abdelrahman, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham Ali Abdelhaleem Abdelrahman, M.D.

CONTACT

00201009136408; rehamali72@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer M.D.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: December 17, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

EG (2)