Pressure Course in the Tube Cuff During Swallowing | NCT00862797

Studies
Pressure Course in the Tube Cuff During Swallowing

NCT00862797

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Anesthesia
Intensive Care

Interventions

pressure measurement during swallowing

Countries

Germany

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

Mar 2009

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

Jan 2008

Primary Completion Date

May 2009Actual

Completion Date

Not provided

First Submitted Date

Mar 16, 2009

First Submission Date that Met QC Criteria

Mar 16, 2009

First Posted Date

Mar 17, 2009Estimated

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

Feb 1, 2010

Last Update Posted Date

Feb 2, 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

Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endotracheal tube		Patients intubated with cuffed endotracheal tubes	Other: pressure measurement during swallowing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pressure measurement during swallowing	Other	measurement of endotracheal tube cuff pressure during swallowing while recovering from anaesthesia	endotracheal tube

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18 years
general anaesthesia or intensive care medicine treatment

Exclusion Criteria:

refusal of written informed consent

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

Patients recovering from general anaesthesia or intensive care patients both intubated with cuffed endotracheal tubes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Steinmann, MD	University Medical Center Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Freiburg		Freiburg im Breisgau		79106	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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