Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

• ClinicalTrials.gov Identifier: NCT03316079
• Recruitment Status: Unknown
• First Posted: October 20, 2017
• Last Update Posted: October 20, 2017
• Sponsor: University Hospital, Bordeaux
• Collaborator: Sociedad Española de Neumología y Cirugía Torácica
• Information provided by (Responsible Party): Roberto Martinez Alejos, University Hospital, Bordeaux

Tracking Information

• First Submitted Date: October 3, 2017
• First Posted Date: October 20, 2017
• Last Update Posted Date: October 20, 2017
• Actual Study Start Date: March 6, 2015
• Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2017)

Mucus volume retrieved [ Time Frame: Immediately after treatment ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 16, 2017)

• Pulmonary mechanics [ Time Frame: Immediately before treatment ]
  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).
• Pulmonary mechanics [ Time Frame: Immediately before treatment ]
  Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
• Pulmonary mechanics [ Time Frame: Immediately before treatment ]
  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).
• Pulmonary mechanics [ Time Frame: Immediately after treatment ]
  Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
• Pulmonary mechanics [ Time Frame: Immediately after treatment ]
  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).
• Pulmonary mechanics [ Time Frame: Immediately after treatment ]
  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).
• Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
  Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
• Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
  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).
• Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
  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).
• Hemodynamic measurements [ Time Frame: Immediately before treatment ]
  Heart Beat per minute (HB) with continous monitoring
• Hemodynamic measurements [ Time Frame: Immediately after treatment ]
  Heart Beat per minute (HB) with continous monitoring
• Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
  Heart Beat per minute (HB) with continous monitoring
• Hemodynamic measurements [ Time Frame: Immediately before treatment ]
  Blood Pressure in mmHg will be measured with continous monitoring
• Hemodynamic measurements [ Time Frame: Immediately after treatment ]
  Blood Pressure in mmHg will be measured with continous monitoring
• Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
  Blood Pressure in mmHg will be measured with continous monitoring
• Arterial blood gases [ Time Frame: Immediately before treatment ]
  pH (in units) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately after treatment ]
  pH (in units) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: 1 hour after treatment ]
  pH (in units) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately before treatment ]
  Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately after treatment ]
  Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: 1 hour after treatment ]
  Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately before treatment ]
  Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately after treatment ]
  Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: 1 hour after treatment ]
  Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately before treatment ]
  Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: Immediately after treatment ]
  Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
• Arterial blood gases [ Time Frame: 1 hour after treatment ]
  Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
• Complications [ Time Frame: Through study completion ]
  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%

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU
• Official Title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Mucus Retention
• Mechanical Ventilation Complication
• 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).

Study Arms

• Active Comparator: Chest physiotherapy techniques
  Manual chest physiotherapy techniques applied
  Intervention: Other: Chest physiotherapy techniques
• Experimental: Chest physiotherapy techniques + Mechanical in-exsufflation
  Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques
  Intervention: Device: Mechanical insufflation-exsufflation

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 16, 2017): 26
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2017
• Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03316079
• Other Study ID Numbers: DC2015/02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Roberto Martinez Alejos, University Hospital, Bordeaux
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Bordeaux
• Original Study Sponsor: Same as current
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica

Investigators

• Principal Investigator: Roberto Martinez Alejos, Msc; University Hospital Bordeaux, France

• PRS Account: University Hospital, Bordeaux
• Verification Date: October 2017