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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01188122
Enrollment
12
Registered
2010-08-25
Start date
2008-04-30
Completion date
2009-09-30
Last updated
2010-08-25

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

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

Brief summary

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.

Interventions

DEVICEAnapnoGuard 100

Respiratory guard system during mechanical ventilation

Sponsors

Hospitech Respiration
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).during intubation (2-14 days)

Secondary

MeasureTime frame
Adverse events occurrenceDuring intubation (2-14 days)

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026