NCT03316079

Brief Summary

Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation. Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

March 6, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

October 3, 2017

Last Update Submit

October 16, 2017

Conditions

Mucus RetentionMechanical Ventilation ComplicationMucus; Plug, Tracheobronchial

Keywords

intensive careinvasive mechanical ventilationmechanical insufflation-exsufflationairway mucus clearancechest physiotherapypeak expiratory flowpulmonary mechanics

Outcome Measures

Primary Outcomes (1)

  • Mucus volume retrieved

    respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container

    Immediately after treatment

Secondary Outcomes (28)

  • Pulmonary mechanics

    Immediately before treatment

  • Pulmonary mechanics

    Immediately before treatment

  • Pulmonary mechanics

    Immediately before treatment

  • Pulmonary mechanics

    Immediately after treatment

  • Pulmonary mechanics

    Immediately after treatment

  • +23 more secondary outcomes

Study Arms (2)

Chest physiotherapy techniques

ACTIVE COMPARATOR

Manual chest physiotherapy techniques applied

Other: Chest physiotherapy techniques

Chest physiotherapy techniques + Mechanical in-exsufflation

EXPERIMENTAL

Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques

Device: Mechanical insufflation-exsufflation

Interventions

Chest physiotherapy techniquesOTHER

Respiratory manual CPT

Chest physiotherapy techniques
Mechanical insufflation-exsufflationDEVICE

CPT + MI-E (4 series of 5 inspiratory-expiratory cycles at +/- 40 cmH2O, 3 seconds of inspiratory time, 2 seconds of expiratory time and 1 second pause between cycles).

Chest physiotherapy techniques + Mechanical in-exsufflation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old.
  • Patents endotracheally intubated (tubes between 7mm and 8mm of internal diameter).
  • Invasive mechanical ventilation \> 48h
  • Invasive mechanical ventilation expected \> 24h
  • RASS between -3 and -5

You may not qualify if:

  • Lung disease with pulmonary parenchyma injury or diseases where mechanical insufflation-exsufflation use is not recommended (eg: emphysema, pneumothorax, pneumomediastinum, hemoptyses, airway instability, acute barotrauma).
  • Hemofiltered patients through a central jugular catheter.
  • Respiratory instability (FiO2) \>60% and/or (PEEP) \> 10cmH2O, and/or hemodynamic instability (MAP) \< 65mmHg although use of vasopressors)\] instability
  • Patients on strict dorsal decubitus by medical prescription.
  • High risk infection patients (eg: tuberculosis, H1N1) that cannot be disconnected from IMV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical ICU

Bordeaux, 33000, France

RECRUITING

Vascular ICU.

Bordeaux, 33000, France

COMPLETED

Polyvalent ICU. Centre medico-chirurgicale Magellan 2.

Pessac, 33600, France

RECRUITING

Related Publications (6)

  • Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41. doi: 10.1378/chest.105.1.237.

    PMID: 8275739RESULT

  • American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

    PMID: 20507660RESULT

  • Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.

    PMID: 18283429RESULT

  • Guerin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.

    PMID: 21801577RESULT

  • Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.

    PMID: 12172066RESULT

  • Martinez-Alejos R, Marti JD, Li Bassi G, Gonzalez-Anton D, Pilar-Diaz X, Reginault T, Wibart P, Ntoumenopoulos G, Tronstad O, Gabarrus A, Quinart A, Torres A. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects. Respir Care. 2021 Sep;66(9):1371-1379. doi: 10.4187/respcare.08641. Epub 2021 Jun 8.

    PMID: 34103385DERIVED

Study Officials

  • Roberto Martinez Alejos, Msc

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Martinez Alejos, Msc

CONTACT

0033 677952556rober.martinez.alejos@gmail.com

Joan Daniel Martí Romeu, PhD

CONTACT

0034 627 95 48 27jd.martibcn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RPT

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 20, 2017

Study Start

March 6, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

FR(3)