Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages (ASPIRE)

Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

Study Overview

• Status: Terminated
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: Intermittent subglottic secretion drainage; Device: Continuous subglottic secretion drainage

Detailed Description

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Service de Réanimation Chirurgicale, Hôpital de Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult aged 18 years or more
• Patients hospitalized in intensive care unit
• Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours

Exclusion Criteria:

• Pregnant or breast-feeding women
• Previous known tracheal lesions
• Persons deprived of freedom

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intermittent drainage; Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.	Device: Intermittent subglottic secretion drainage; Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
ACTIVE_COMPARATOR: Continuous drainage.; Continuous subglottic secretion drainage at -20 mmHg.	Device: Continuous subglottic secretion drainage; Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal mucosal damages assessed by tracheal fibroscopy.	stage 0: no lesion; stage 1: erythema; stage 2 : oedema; stage 3 : ulceration; stage 4 : necrosis	the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)

Secondary Outcome Measures

Outcome Measure	Time Frame
Volume of daily secretions	During intubation
Occurrence of difficulties or impossibilities of secretion drainage	During intubation
Occurrence of ventilator-associated pneumonia	During intubation

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Publications and helpful links

General Publications

• Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (ESTIMATE): March 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Ventilator-associated pneumonia; Secretion drainage; Tracheal fibroscopy
• Other Study ID Numbers: 2010-A00912-37; CIC0203/124 (OTHER: RennesClinicalSearchCenter); LOC/09-05 (OTHER: Rennes University Hospital)