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NCT Number: NCT01082666

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

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

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ICU, Calmette Hospital, University Hospital of Lille

Lille, Nord, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous control of cuff pressure

Device

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

Other names: Automatic control of cuff pressure (Rusch, Kernen, Germany)

Manual control of cuff pressure

Device

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

Other names: Manual manometer

Primary outcomes

  1. Pepsin level in tracheal aspirate

    Time frame: 48 h after randomization

Secondary outcomes

  1. Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions

    Time frame: day 28 after randomization

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 8, 2010
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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