Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

Not Applicable

• Conditions: Mucus Retention; Mechanical Ventilation Complication; Mucus; Plug, Tracheobronchial
• Interventions: Other: Chest physiotherapy techniques; Device: Mechanical insufflation-exsufflation

• Registration Number: NCT03316079
• Lead Sponsor: University Hospital, Bordeaux

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 Timeline

• Study Start: 2015-03-06
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-16
• Last Update Submitted: 2017-10-16
• Study First Posted: 2017-10-20
• Last Update Posted: 2017-10-20
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chest physiotherapy techniques	Chest physiotherapy techniques	Manual chest physiotherapy techniques applied
Chest physiotherapy techniques + Mechanical in-exsufflation	Mechanical insufflation-exsufflation	Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques

Primary Outcome Measures

Name	Time	Method
Mucus volume retrieved	Immediately after treatment	respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container

Secondary Outcome Measures

Name	Time	Method
Pulmonary mechanics	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).
Arterial blood gases	1 hour after treatment	Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Hemodynamic measurements	1 hour after treatment	Blood Pressure in mmHg will be measured with continous monitoring
Complications	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%

Trial Locations

Locations (3)

Medical ICU; 🇫🇷 Bordeaux, France

Vascular ICU.; 🇫🇷 Bordeaux, France

Polyvalent ICU. Centre medico-chirurgicale Magellan 2.; 🇫🇷 Pessac, France