Ventilation With Supraglottic Airway Devices

NCT04421261 | Completed DMC

• 1 other identifier: KR-1990
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.

Conditions

Laryngeal Masks Comparison

Outcome Measures

Primary Outcomes (1)

• oropharyngeal leak pressure

  pressure at which air leak starts to occur

  1 year

Study Arms (2)

Air-Q Self Pressurized Airway Device with Blocker

Device: Air-Q Self Pressurized Airway Device with Blocker

Proseal Laryngeal Mask Airway

Device: Proseal Laryngeal Mask Airway

Interventions

Air-Q Self Pressurized Airway Device with Blocker DEVICE

used in low risk adult females undergoing elective surgeries

Air-Q Self Pressurized Airway Device with Blocker

Proseal Laryngeal Mask Airway DEVICE

used in low risk adult female patients undergoing elective surgeries

Proseal Laryngeal Mask Airway

Eligibility Criteria

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

Study Population

Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals

You may qualify if:

• Adult female patients ASA I\&II.
• age: 18-55 years old.
• BMI\< 35.
• undergoing elective surgeries.

You may not qualify if:

• Patients with history of upper respiratory tract infections and obstructive sleep apnea.
• Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
• Patients with coagulation disorders.
• Patients with El-Ganzouri airway score ≥ 5 will.

Sponsors & Collaborators

• Reham Ali Abdelhaleem Abdelrahman: lead

Study Sites (1)

Department of anesthesia, Surgical ICU and Pain Management

Cairo, 11562, Egypt

Location

Study Design

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

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: June 4, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

EG (1)