Proseal Laryngeal Mask Airway Placement Videolaryngoscope Guided Versus Classic Technique

A Prospective Randomized Study ProSeal Laryngeal Mask Airway Placement Videolaryngoscpe-Guided Versus Classic Digital Technique - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068309

Enrollment

Registered

2024-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: ProSeal Laryngeal Mask Airway Placement: ProSeal Laryngeal Mask Airway Placement Videolaryngoscope-Guided Versus Classic Digital Technique Control Intervention1: N/A: N/A

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with physical status ASA grade I or II. 2.All patients giving written informed consent. 3.Patients undergoing lower abdominal elective surgery under general anaesthesia. 4.Patients belonging to age group of 18 to 65 years

Exclusion criteria

Exclusion criteria: 1. Patient refusal for the procedure. 2. Patient with anaemia. 3. ASA grade 3 and 4 4. Patient with significant coagulopathies. 5. Patient with known or suspected pregnancy. 6. Patient with renal or liver disease. 7. Non fasting patients. 8. Patients on antipsychotic medication. 9. Patients with increased risk of aspiration. 10. Patients with BMI more than 35 kg per square meter 11. Patients with difficult airway. 12. Patients having cervical spine diseases 13. Patients with pre-existing sore throat or hoarseness

Design outcomes

Primary

Measure	Time frame
To compare the number of attempts, insertion time, leak volume, fibreoptic score, peak inspiratory pressure, to insert ProSeal LMA with videolaryngoscope D blade versus classic digital technique.Timepoint: Number of attempts to insert ProSeal LMA -3 attempts Insertion time of ProSeal LMA-3minutes Leak volume at 15 minutes Fibre optic score at 3 minutes Peak inspiratory pressure at 15 minutes Oropharyngeal leak at 15 minutes	—

Measure

Time frame

To compare the number of attempts, insertion time, leak volume, fibreoptic score, peak inspiratory pressure, to insert ProSeal LMA with videolaryngoscope D blade versus classic digital technique.Timepoint: Number of attempts to insert ProSeal LMA -3 attempts Insertion time of ProSeal LMA-3minutes Leak volume at 15 minutes Fibre optic score at 3 minutes Peak inspiratory pressure at 15 minutes Oropharyngeal leak at 15 minutes

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Secondary

Measure	Time frame
1. To compare the hemodynamic changes HR, SBP, DBP, MAP, SpO2 at various time intervals in both study groups. 2. To compare the complications and adverse effects of both the insertion techniques. Timepoint: 1- Hemodynamic changes observation T0 -Baseline/Before induction T1-Immediately after induction T2-1 minute after insertion T3- 3 minute after insertion T4- 5 minutes after insertion T5- 10 minutes after insertion 2-post extubation complications: Blood stains on ProSeal LMA or videolaryngoscope Sore throat Hoarseness Dysphagia Cough Vomiting Bronchospasm	—

Measure

Time frame

1. To compare the hemodynamic changes HR, SBP, DBP, MAP, SpO2 at various time intervals in both study groups. 2. To compare the complications and adverse effects of both the insertion techniques. Timepoint: 1- Hemodynamic changes observation T0 -Baseline/Before induction T1-Immediately after induction T2-1 minute after insertion T3- 3 minute after insertion T4- 5 minutes after insertion T5- 10 minutes after insertion 2-post extubation complications: Blood stains on ProSeal LMA or videolaryngoscope Sore throat Hoarseness Dysphagia Cough Vomiting Bronchospasm

—

Countries

India

Contacts

Public ContactBabita Ramdev

MMIMSR

babitaramdev30@gmail.com7888554917

Outcome results

None listed

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