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Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

NCT ID: NCT01351259

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

Detailed Description

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Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Conditions

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Mechanical Ventilation Complication Tracheal Intubation Morbidity

Keywords

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Mechanical ventilation Intubation Cuff pressure Microaspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pneumatic device, tapered cuff

Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff

Group Type EXPERIMENTAL

Pneumatic device, cylindrical or tapered cuff

Intervention Type DEVICE

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Pneumatic device, cylindrical cuff

Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes

Group Type EXPERIMENTAL

Pneumatic device, cylindrical or tapered cuff

Intervention Type DEVICE

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Routine care, tapered cuff

Routine care of cuff pressure using a manometer, tapered polyurethane cuff

Group Type ACTIVE_COMPARATOR

Pneumatic device, cylindrical or tapered cuff

Intervention Type DEVICE

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Routine care, cylindrical cuff

Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff

Group Type ACTIVE_COMPARATOR

Pneumatic device, cylindrical or tapered cuff

Intervention Type DEVICE

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Interventions

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Pneumatic device, cylindrical or tapered cuff

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Intervention Type DEVICE

Other Intervention Names

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Nosten Kimberly clark Covidien

Eligibility Criteria

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Inclusion Criteria

* Patients requiring intubation in the ICU
* Predicted duration of mechanical ventilation \> or = 48h
* Age \> or = 18 years

Exclusion Criteria

* Contraindication for semirecumbent position
* Contraindication for enteral nutrition
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Saad NSEIR

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saad NSEIR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Locations

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ICU, Calmette Hospital, CHU de Lille

Lille, Nord, France

Site Status

Countries

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France

References

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Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.

Reference Type DERIVED
PMID: 24369057 (View on PubMed)

Other Identifiers

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2009_20/0925

Identifier Type: OTHER

Identifier Source: secondary_id

2009-A00598-49

Identifier Type: -

Identifier Source: org_study_id