COMPARISION OF TWO LARYNGEAL MASK AIRWAY DEVICES IN MANAGEMENT OF PATIENTS UNDERGOING OPERATIVE PROCEDURE

A COMPARATIVE EVALUATION OF LMA PROSEAL AND LMA AMBU AURA40 IN ADULT PATIENTS UNDERGOING OPERATIVE PROCEDURE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/039934

Enrollment

Registered

2022-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: K80- Cholelithiasis Health Condition 2: N97- Female infertility Health Condition 3: N84- Polyp of female genital tract Health Condition 4: H66- Suppurative and unspecified otitismedia Health Condition 5: N63- Unspecified lump in breast

Interventions

Intervention1: LMA Ambu Aura40: Airway management of patients undergoing operative procedure under General Anaesthesia Control Intervention1: LMA Proseal: Airway management of patients undergoing oper

Eligibility

Inclusion criteria

Inclusion criteria: 1.Written and informed consent from the patient 2.ASA grade 1 and 2 patients 3.All Mallampatti grades

Exclusion criteria

Exclusion criteria: 1.Mouth opening 2.Patients with known difficult airway 3.Potentially full stomach patients (trauma, morbid obesity, pregnancy, GERD). 4.Cervical spine fracture or instability 5.History of allergy to latex

Design outcomes

Primary

Measure	Time frame
Insertion timeTimepoint: Insertion time shall be calculated from the time of introduction of the device into the mouth till confirmation by capnographic tracing.	—

Secondary

Measure	Time frame
1.To compare the ease of insertion of both the devices. 2.To compare the hemodynamics response i.e, Heart Rate and Mean Arterial Blood Pressure (MABP) after insertion. 3.To compare the incidence of complications. Timepoint: Grade 1: No resistance to insertion in the pharynx. Grade 2: Mild resistance to insertion. Grade 3: Moderate to severe resistance to insertion. Grade 4: Failed insertion. Heart rate and MABP shall be recorded from a standard multichannel monitor.(pre induction, post insertion, and after 3 minutes,5 minutes and 10 minutes). Complications shall be assessed by presence or absence of blood on device after removal and post operative sore throat	—

Measure

Time frame

1.To compare the ease of insertion of both the devices. 2.To compare the hemodynamics response i.e, Heart Rate and Mean Arterial Blood Pressure (MABP) after insertion. 3.To compare the incidence of complications. Timepoint: Grade 1: No resistance to insertion in the pharynx. Grade 2: Mild resistance to insertion. Grade 3: Moderate to severe resistance to insertion. Grade 4: Failed insertion. Heart rate and MABP shall be recorded from a standard multichannel monitor.(pre induction, post insertion, and after 3 minutes,5 minutes and 10 minutes). Complications shall be assessed by presence or absence of blood on device after removal and post operative sore throat

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Countries

India

Contacts

Public ContactAmaan Quadir

Jawaharlal Nehru Medical College, Aligarh Muslim University

syedkamranhabib@gmail.com9897172780

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026