Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery (Ventinova ORL)

Hopital Foch

Status: Terminated

Conditions: Laryngeal Disease

Treatments: Device: Flow Controlled Ventilation using a laryngeal tri-tube; Device: High-flow nasal oxygen therapy using a specific nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04369040

2020_0016

Details and patient eligibility

About

Single-center, randomized study, comparing two methods of oxygenation on 80 patients

Full description

This study is a single-center, randomized study, comparing two methods of oxygenation during micro-laryngeal surgery performed under general anesthesia and myorelaxation: high-flow nasal oxygen therapy (HFNO) or Flow Controlled Ventilation (FCV) using a laryngeal tri-tube. The study population will be composed of 80 patients, aged over 18 and under 80.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over the age of 18 and under the age of 80
• Patient to benefit from micro-laryngeal ENT surgery under general anesthesia and myorelaxation with an estimated duration which does not exceed 30 minutes
• Having signed a consent form
• Being affiliated with a Health Insurance plan.

Exclusion criteria

• Pregnant or lactating patient
• Patient with a weight <40 kg
• Obese patient (BMI> 30)
• Patient with foreseeable intubation difficulty
• Patient maintained under general anesthesia postoperatively
• Surgery requiring time by surgical laser
• Surgery involving the use of an active electrosurgical electrode in the immediate area of the electrosurgical device or electrode
• Predictable surgery longer than 30 minutes
• Being deprived of liberty or under guardianship.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

High-flow nasal oxygen therapy

Other group

Description:

Ventilation with High-flow nasal oxygen therapy

Treatment:

Device: High-flow nasal oxygen therapy using a specific nasal cannula

Flow Controlled Ventilation

Experimental group

Description:

Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique

Treatment:

Device: Flow Controlled Ventilation using a laryngeal tri-tube