Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System

Hospitech Respiration

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Device: AnapnoGuard 100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01188122

HST -AG -01

Details and patient eligibility

About

Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.

This study was design in order to evaluate the feasibility of using the AnapnoGuard system.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 (men and woman);
• Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
• Normal chest X-ray;
• Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
• Signed informed consent by subject's legally acceptable representative.

Exclusion criteria

• Patients who had been treated with mechanical ventilation during the last year;
• Fever from known chest/lung origin;
• Patients with facial, oropharyngeal or neck trauma;
• BMI>35;
• Height < 1.6 m;
• Any chest X-ray pathology during the first 24 hours post intubation;
• More than 7 days hospitalization prior to the intubation. Chest/lung infection.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

AnapnoGuard

Experimental group

Treatment:

Device: AnapnoGuard 100