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A study to check the safety and feasibility of Laryngeal Mask Airways with wide gastric port for Trans-esophageal Echocardiography guided cardiac catheterisation procedures.

Safety and Feasibility of Second Generation Laryngeal Mask Airways with wide gastric port for Trans-esophageal Echocardiography guided trans-catheter device closure procedures: a prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/047811
Enrollment
30
Registered
2022-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Observational study.

Sponsors

Dr Sanjeeta Rajendra Umbarkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Patients posted for percutaneous device closure procedures under TEE guidance. II. Mouth opening >35mm. III. Mallampati score 1or2 IV. Weight >30 kg. V. Strict NBM.

Exclusion criteria

Exclusion criteria: I. Hemodynamically unstable. II. Patient at risk of aspiration. III. Difficult intubation. IV. Edentulous. V. Surgery duration >3hrs. VI. Significant acute or chronic lung disease VII. Known airway problems.

Design outcomes

Primary

MeasureTime frame
To check feasibility and safety of second generation LMA with wide gastric port in ease of TEE probe placement and efficient airway management of patients in percutaneous device closure procedures requiring TEE.Timepoint: From start of procedure to 24hrs post procedure in ICU.

Secondary

MeasureTime frame
1) To observe success rate of TEE probe insertion. 2) To observe success rate of LMA insertion. 3) To observe ease of LMA insertion. 4) To note presence of sore throat after LMA removal. 5) To note visualisation of blood on the LMA after removal. 6) To note any airway compromise after LMA removal. 7) To note post-operative laryngospasm 8) To note damage to Trans esophageal echocardiography probe.Timepoint: From start of procedure to 24hrs post procedure in ICU.

Countries

India

Contacts

Public ContactDr Parimal Makarand Pimpalkhute

Seth G S Medical College And KEM Hospital, Mumbai

sanjeetaumbarkar@kem.edu9323273435

Outcome results

None listed

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