Optimal Endotracheal Cuff Pressure During Hospitalization... | NCT01188122

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

NCT01188122

Sponsor

Hospitech Respiration

Status

Completed

Last Update Posted

Aug 25, 2010Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Ventilator Associated Pneumonia

Interventions

AnapnoGuard 100

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 23, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2010

Last Update Posted Date

Aug 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AnapnoGuard	Experimental		Device: AnapnoGuard 100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AnapnoGuard 100	Device	Respiratory guard system during mechanical ventilation	AnapnoGuard

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 Outcomes

Measure	Description	Time Frame
Adverse events occurrence		During intubation (2-14 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marian Popescu, Dr.	Spitalu Universitar De Urgenta Elias Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spitalu Universitar De Urgente Elias Hospital		Bucharest			Romania

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided