Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

Mechanical Ventilation Complication Clinical Trial

Official title:

Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03316079
• Other study ID #: DC2015/02
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2017
• Last updated: October 16, 2017
• Start date: March 6, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Bordeaux
• Contact: Roberto Martinez Alejos, Msc
• Phone: 0033 677952556
• Email: rober.martinez.alejos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria :

• 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

Exclusion criteria :

• 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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Mucus Retention
• Mucus; Plug, Tracheobronchial

Intervention

Other:
• Chest physiotherapy techniques
Respiratory manual CPT

Device:
• Mechanical insufflation-exsufflation
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).

Locations

Country	Name	City	State
France	Medical ICU	Bordeaux
France	Vascular ICU.	Bordeaux
France	Polyvalent ICU. Centre medico-chirurgicale Magellan 2.	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Gómez-Merino E, Sancho J, Marín 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):5 — View Citation

Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer 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 — View Citation

Guérin 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 — View Citation

Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucus volume retrieved	respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container	Immediately after treatment
Secondary	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).	Immediately before treatment
Secondary	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).	Immediately before treatment
Secondary	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).	Immediately before treatment
Secondary	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).	Immediately after treatment
Secondary	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).	Immediately after treatment
Secondary	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).	Immediately after treatment
Secondary	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).	1 hour after treatment
Secondary	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).	1 hour after treatment
Secondary	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).	1 hour after treatment
Secondary	Hemodynamic measurements	Heart Beat per minute (HB) with continous monitoring	Immediately before treatment
Secondary	Hemodynamic measurements	Heart Beat per minute (HB) with continous monitoring	Immediately after treatment
Secondary	Hemodynamic measurements	Heart Beat per minute (HB) with continous monitoring	1 hour after treatment
Secondary	Hemodynamic measurements	Blood Pressure in mmHg will be measured with continous monitoring	Immediately before treatment
Secondary	Hemodynamic measurements	Blood Pressure in mmHg will be measured with continous monitoring	Immediately after treatment
Secondary	Hemodynamic measurements	Blood Pressure in mmHg will be measured with continous monitoring	1 hour after treatment
Secondary	Arterial blood gases	pH (in units) will be obtained from radial artery and blood gases analyzed.	Immediately before treatment
Secondary	Arterial blood gases	pH (in units) will be obtained from radial artery and blood gases analyzed.	Immediately after treatment
Secondary	Arterial blood gases	pH (in units) will be obtained from radial artery and blood gases analyzed.	1 hour after treatment
Secondary	Arterial blood gases	Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.	Immediately before treatment
Secondary	Arterial blood gases	Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.	Immediately after treatment
Secondary	Arterial blood gases	Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.	1 hour after treatment
Secondary	Arterial blood gases	Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.	Immediately before treatment
Secondary	Arterial blood gases	Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.	Immediately after treatment
Secondary	Arterial blood gases	Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.	1 hour after treatment
Secondary	Arterial blood gases	Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.	Immediately before treatment
Secondary	Arterial blood gases	Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.	Immediately after treatment
Secondary	Arterial blood gases	Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.	1 hour after treatment
Secondary	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%	Through study completion