Mucus RetentionNCT03316079
Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU
A study testing Chest physiotherapy techniques and Mechanical insufflation-exsufflation in people with Mucus Retention and Mechanical Ventilation Complication, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mucus Retention, Mechanical Ventilation Complication, Mucus; Plug, Tracheobronchial
- What is being tested?
- Chest physiotherapy techniques and Mechanical insufflation-exsufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Mar 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 2 recruiting
- Recruiting
Medical ICU
Bordeaux, 33000
Thomas Reginault, RPT, 00 33 616 18 13 40, thomas.reginault@chu-bordeaux.fr
Xabier Pilar Diaz, Msc
- Completed
Vascular ICU.
Bordeaux, 33000
- Recruiting
Polyvalent ICU. Centre medico-chirurgicale Magellan 2.
Pessac, 33600
Roberto Martinez Alejos, Msc, 0033 677952556, rober.martinez.alejos@gmail.com
Alice Quinart, PhD, MD
About this study
Official title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
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.
Read the detailed description
Controlled randomized, cross-over, single blind trial conducted at University Hospital of Bordeaux (France).
Inclusion criteria: Patients (>18 yo) intubated [internal diameter (ID) 7 to 8], sedated [Richmond Agitation Sedation Scale (RASS) -3 to -5], connected to IMV at least 48 h and expected IMV of at least 24h.
Exclusion criteria: Lung disease or pulmonary parenchyma damage, respiratory inspired fraction of oxygen (FiO2) >60% and/or positive end-expiratory pressure (PEEP) > 10 centimetres of water (cmH2O) and/or hemodynamic instability (mean arterial pressure (MAP) < 65 millimetres of mercury (mmHg) although use of vasopressors] , hemofiltered patients through a central jugular catheter, patients on strict dorsal decubitus by medical prescription, and high respiratory infectious risk.
Design: All patients will receive CPT followed by ETS twice daily. However, patients will randomly receive in one of the sessions an additional treatment of MI-E before ETS. MI-E treatment consists in 4 series of 5 in-expiratory cycles at +/- 40 cmH2O, 3 and 2 sec of inspiratory-expiratory time and 1 sec pause between cycles.
Variables: Mucus clearance will be assessed through wet volume of suctioned sputum through a suction catheter connected to a sterile collector container. Pulmonary mechanics will be measured before, after and 1 h post-intervention through a pneumotachograph (PNT). Peak expiratory flow (PEF) generated by MI-E will be continuously measured through a PNT. Hemodynamic measurements will be recorded before, after and 1 h post-intervention.
- Being tested
- Chest physiotherapy techniques, Mechanical insufflation-exsufflation
- Keywords
- intensive care, invasive mechanical ventilation, mechanical insufflation-exsufflation, airway mucus clearance, chest physiotherapy, peak expiratory flow, pulmonary mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy techniquesOther
Respiratory manual CPT
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).
| Study group | Role | What they receive |
|---|---|---|
| Chest physiotherapy techniques | Active comparator | Manual chest physiotherapy techniques applied Receives: Other: Chest physiotherapy techniques |
| Chest physiotherapy techniques + Mechanical in-exsufflation | Experimental | Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques Receives: Device: Mechanical insufflation-exsufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucus volume retrieved
respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container
Measured: Immediately after treatment
Secondary outcomes (28)
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Measured: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Measured: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Measured: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Measured: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Measured: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Measured: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Measured: 1 hour after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Measured: 1 hour after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Measured: 1 hour after treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Measured: Immediately before treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Measured: Immediately after treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Measured: 1 hour after treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Measured: Immediately before treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Measured: Immediately after treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Measured: 1 hour after treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately before treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately after treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Measured: 1 hour after treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately before treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately after treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: 1 hour after treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately before treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately after treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Measured: 1 hour after treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately before treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Measured: Immediately after treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Measured: 1 hour after treatment
Complications
We will asess the following adverse events that could happen while we will applying protocol:
- Mean arterial pressure lower than 15% from baseline
- Systolic blood pressure higher or lower than 15% from baseline
- Diastolic blood pressure higher or lower than 15% from baseline
- Heart rate higher or lower than 20% from baseline
- Oxygen saturation < 85%
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start6 Mar 2015
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mucus RetentionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, Roberto Martinez Alejos, University Hospital, Bordeaux
- Investigators
- Roberto Martinez Alejos, Msc, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316079
- Sponsor's protocol ID
- DC2015/02
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8275739American 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.
PubMed 20507660Gosselink 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.
PubMed 18283429Guerin 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.
PubMed 21801577Gomez-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.
PubMed 12172066Martinez-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.
PubMed 34103385
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03316079
- Acronym / sponsor ID
- DC2015/02
- Keywords
- intensive care, invasive mechanical ventilation, mechanical insufflation-exsufflation, airway mucus clearance, chest physiotherapy, peak expiratory flow, pulmonary mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Controlled randomized, cross-over, single blind trial conducted at University Hospital of Bordeaux (France).
Inclusion criteria: Patients (>18 yo) intubated [internal diameter (ID) 7 to 8], sedated [Richmond Agitation Sedation Scale (RASS) -3 to -5], connected to IMV at least 48 h and expected IMV of at least 24h.
Exclusion criteria: Lung disease or pulmonary parenchyma damage, respiratory inspired fraction of oxygen (FiO2) >60% and/or positive end-expiratory pressure (PEEP) > 10 centimetres of water (cmH2O) and/or hemodynamic instability (mean arterial pressure (MAP) < 65 millimetres of mercury (mmHg) although use of vasopressors] , hemofiltered patients through a central jugular catheter, patients on strict dorsal decubitus by medical prescription, and high respiratory infectious risk.
Design: All patients will receive CPT followed by ETS twice daily. However, patients will randomly receive in one of the sessions an additional treatment of MI-E before ETS. MI-E treatment consists in 4 series of 5 in-expiratory cycles at +/- 40 cmH2O, 3 and 2 sec of inspiratory-expiratory time and 1 sec pause between cycles.
Variables: Mucus clearance will be assessed through wet volume of suctioned sputum through a suction catheter connected to a sterile collector container. Pulmonary mechanics will be measured before, after and 1 h post-intervention through a pneumotachograph (PNT). Peak expiratory flow (PEF) generated by MI-E will be continuously measured through a PNT. Hemodynamic measurements will be recorded before, after and 1 h post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest physiotherapy techniques | Active comparator | Other: Chest physiotherapy techniquesManual chest physiotherapy techniques applied |
| Chest physiotherapy techniques + Mechanical in-exsufflation | Experimental | Device: Mechanical insufflation-exsufflationMechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy techniquesRespiratory manual CPT | Other | Chest physiotherapy techniques |
| Mechanical insufflation-exsufflationCPT + 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). | Device | Chest physiotherapy techniques + Mechanical in-exsufflation |
Primary outcome
Mucus volume retrieved
Time frame: Immediately after treatment
respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container
28 secondary outcomes
Pulmonary mechanics
Time frame: Immediately before treatment
Pulmonary mechanics
Time frame: Immediately before treatment
Pulmonary mechanics
Time frame: Immediately before treatment
Pulmonary mechanics
Time frame: Immediately after treatment
Pulmonary mechanics
Time frame: Immediately after treatment
Pulmonary mechanics
Time frame: Immediately after treatment
Pulmonary mechanics
Time frame: 1 hour after treatment
Pulmonary mechanics
Time frame: 1 hour after treatment
Pulmonary mechanics
Time frame: 1 hour after treatment
Hemodynamic measurements
Time frame: Immediately before treatment
Hemodynamic measurements
Time frame: Immediately after treatment
Hemodynamic measurements
Time frame: 1 hour after treatment
Hemodynamic measurements
Time frame: Immediately before treatment
Hemodynamic measurements
Time frame: Immediately after treatment
Hemodynamic measurements
Time frame: 1 hour after treatment
Arterial blood gases
Time frame: Immediately before treatment
Arterial blood gases
Time frame: Immediately after treatment
Arterial blood gases
Time frame: 1 hour after treatment
Arterial blood gases
Time frame: Immediately before treatment
Arterial blood gases
Time frame: Immediately after treatment
Arterial blood gases
Time frame: 1 hour after treatment
Arterial blood gases
Time frame: Immediately before treatment
Arterial blood gases
Time frame: Immediately after treatment
Arterial blood gases
Time frame: 1 hour after treatment
Arterial blood gases
Time frame: Immediately before treatment
Arterial blood gases
Time frame: Immediately after treatment
Arterial blood gases
Time frame: 1 hour after treatment
Complications
Time frame: Through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Results publication: PubMed 8275739Konrad 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.
- Results publication: PubMed 20507660American 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.
- Results publication: PubMed 18283429Gosselink 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.
- Results publication: PubMed 21801577Guerin 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.
- Results publication: PubMed 12172066Gomez-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.
- Derived from this study: PubMed 34103385Martinez-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.
- Individual participant dataSharing planned: Undecided
Related trials for Mucus Retention
Recruiting
Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Mucus Retention, Mechanical Ventilation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Martinez Alejos, Msc principal investigator
University Hospital Bordeaux, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy techniques and Mechanical insufflation-exsufflation in people with Mucus Retention and Mechanical Ventilation Complication, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Martinez Alejos, Msc (0033 677952556, rober.martinez.alejos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucus volume retrieved (time frame: Immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316079, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.