Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082666

Enrollment

122

Registered

2010-03-08

Start date

2009-10-01

Completion date

2010-12-01

Last updated

2026-04-22

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

Conditions

Critically Ill

Keywords

Cuff pressure, microaspiration, pepsin, VAP, Mechanical ventilation

Brief summary

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed description

Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O. In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Interventions

DEVICEContinuous control of cuff pressure

Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)

DEVICEManual control of cuff pressure

Manual control of cuff pressure is a routine practice in ICU patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age \> or = 18 years * tracheal intubation using a polyvinylchloride tube * predictible duration of mechanical ventilation \> 48 h * enteral nutrition

Exclusion criteria

* refuse to participate to the study * no informed consent * contra-indication for semirecumbment position

Design outcomes

Primary

Measure	Time frame
Pepsin level in tracheal aspirate	48 h after randomization

Secondary

Measure	Time frame
Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions	day 28 after randomization

Countries

France

Contacts

STUDY_DIRECTORAlain Durocher, MD

CHRU de Lille

STUDY_DIRECTORMalika Balduyck, MD

CHU de Lille

STUDY_DIRECTORFarid Zerimech, MD