Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

Study Overview
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Brief Summary
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Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning. Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.

Detailed Description
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Secretion suctioning (SS) in patients with artificial airway is a mandatory procedure, although occasionally painful, not tolerated and even causing traumatic injury to the respiratory mucosa. Mechanical insufflation-exsufflation (MIE) and nebulized hypertonic saline with hyaluronic acid (HS-HA) have shown efficacy and safety in patients with chronic neuromuscular and pulmonary diseases, achieving aspiration and fluidification of respiratory secretions, respectively, as well as good tolerance. Only anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available. Background: Both MIE and HS-HA facilitate the drainage of secretions from the distal airway (compared to conventional catheter suctioning, the effect of which is supposed to be limited to the trachea) Both measures may prove to be efficacious in the prevention (through airway clearance of secretions) and concomitant treatment (reduction of inoculum or draining the lung) of lower respiratory tract infections (tracheobronchitis and pneumonia).

Official Title
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A Randomized Study on the Safety and Tolerability of Mechanical Insufflation-exsufflation and Hypertonic Saline With Hyaluronic Acid for Suctioning of Respiratory Tract Secretions in Patients With Artificial Airway

Conditions
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Endotracheal Tube, Tracheostomy

Intervention / Treatment
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* Device: Catheter secretion suctioning
* Combination Product: Secretion suctioning + hypertonic saline
* Device: Ins-exsufflation
* Combination Product: Ins-exsufflation + Hypertonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff. Need for aspiration of secretions Informed consent Exclusion Criteria: Macroscopic hemoptysis. Acute bronchospasm Uncrontrolled muscular contractions, like tremor, myoclonus or other. Confirmed pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized, four groups of different respiratory tract secretion suctioning methods: 1) catheter (conventional), 2) catheter after hypertonic saline, 3) mechanical insufflation-exsufflation, and 4) mechanical insufflation-exsufflation with hypertonic saline
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catheter secretion suctioning<br>Secretions are aspirated with a catheter at -120 to -150 mBar | Device: Catheter secretion suctioning<br>* Catheter secretion suctioning with prior nebulization of hypertonic saline<br>|
| Experimental: Secretion suctioning + hypertonic saline<br>Hypertonic saline is nebulized prior to aspiration of secretions. | Combination Product: Secretion suctioning + hypertonic saline<br>* Catheter secretion suctioning with prior nebulization of hypertonic saline<br>|
| Experimental: Ins-exsufflation<br>Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg | Device: Ins-exsufflation<br>* Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning<br>|
| Experimental: Ins-exsufflation + Hypertonic Saline<br>Mechanical insufflation-exsufflation and hypertonic saline | Combination Product: Ins-exsufflation + Hypertonic saline<br>* Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline. | Comparative incidence of aggregate hemodynamic and respiratory adverse events. Adverse events criteria are predefined and will be expressed as: Percentage of patients meeting aggregate predefined hemodynamic or respiratory adverse event criteria per study group. Percentage of specific predefined adverse events (outcome variable yes or no): Desaturation (pulse-oximetry, >5%), hemoptisis (yes or no), bronchospasm (needing bronchodilator therapy), pneumothorax (as assessed by chest X-ray), hypotension (>30% or >10% increase in noradrenaline infusion from baseline), hypertension (>30% or >10% decrease in noradrenaline infusion from baseline), tachycardia (>90 bpm or >30% increase), bradycardia (<40 bpm), arrythmias (supra ventricular, requiring therapy), atelectasis (as assessed by chest X-ray), and other complications occuring during or within 1 hour after the procedure. | 1 hour | 
| Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems. | Comparative pain scores of the study procedures in the 4 study groups will be assessed using the ESCID pain score (EScala de Conductas Indicadoras de Dolor, ranging from 0, no pain, to >6, intense pain, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions. Both comparison of the score at the 4 study time-points and their variations between time-points will be analysed. | 1 hour | 
| Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system. | Comparative sedation/agitation score of the study procedures in the 4 study groups will be assessed using the RASS (Richmond Agitation-Sedation Scale, see citations), range -5, un-arousable, to +5, combative) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions. | 1 hour | 
| Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system. | Comparative sedation/responsiveness score of the study procedures in the 4 study groups will be assessed using the responsiveness Ramsay Sedation Scale, range from 1, anxious and agitated, to 6, no response to stimulus, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory secretion suctioning, mechanical insufflation exsufflation, hypertonic saline, hyaluronic acid, critically ill, artificial airway