NCT01948635

Brief Summary

The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 22, 2025

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

August 31, 2013

Last Update Submit

December 15, 2025

Conditions

Critical IllnessMechanical Ventilation ComplicationVentilator Associated Pneumonia

Keywords

tracheal cuff shapemicroaspirationpepsinventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • Microaspiration of gastric contents

    Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents

    48 hours after randomization

Secondary Outcomes (3)

  • Microaspiration of oropharyngeal secretions

    48 h after randomization

  • Tracheobronchial colonization

    28 days after randomization

  • Ventilator-associated pneumonia

    28 days after randomization

Study Arms (2)

tapered PVC-cuffed tracheal tubes

EXPERIMENTAL

Patients in this arm will be intubated with tapered PVC-tracheal tubes

Device: tapered PVC-cuffed tracheal tubes

Standard PVC-cuffed tracheal tube

ACTIVE COMPARATOR

Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes

Device: Standard PVC-cuffed tracheal tube

Interventions

tapered PVC-cuffed tracheal tubesDEVICE

Patients will be intubated with tapered-shape tracheal tubes

tapered PVC-cuffed tracheal tubes
Standard PVC-cuffed tracheal tubeDEVICE

Patients will be intubated with standard PVC cuffed tracheal tubes

Standard PVC-cuffed tracheal tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> or = 18 years
  • tracheal intubation
  • predictable duration of mechanical ventilation \> 48h
  • enteral nutrition

You may not qualify if:

  • pregnant women
  • refuse to participate to the study
  • no informed consent
  • contre indication for semirecumbent position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, 59035, France

Location

centre Hospitalier

Boulogne-sur-Mer, France

Location

Centre Hospitalier

Dunkirk, France

Location

Centre Hospitalier

Lens, France

Location

Centre Hospitalier St Philibert

Lomme, France

Location

Centre hospitalier

Roubaix, France

Location

Centre Hospitalier Universitaire

Rouen, France

Location

Centre Hospitalie

Tourcoing, France

Location

Centre Hospitalier

Valenciennes, France

Location

Related Publications (2)

  • Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.

    PMID: 26407612BACKGROUND

  • Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.

    PMID: 28303301RESULT

MeSH Terms

Conditions

Critical IllnessPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic Disease

Study Officials

  • Saad Nseir, MD, PhD

    CHRU de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2013

First Posted

September 23, 2013

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 22, 2025

Record last verified: 2018-05

Locations

FR(9)