Endotracheal Tube, Tracheostomy
Conditions
Keywords
respiratory secretion suctioning, mechanical insufflation exsufflation, hypertonic saline, hyaluronic acid, critically ill, artificial airway
Brief summary
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
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).
Interventions
DEVICECatheter secretion suctioning
Catheter secretion suctioning with prior nebulization of hypertonic saline
COMBINATION_PRODUCTSecretion suctioning + hypertonic saline
Catheter secretion suctioning with prior nebulization of hypertonic saline
DEVICEIns-exsufflation
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
COMBINATION_PRODUCTIns-exsufflation + Hypertonic saline
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Sponsors
Chiesi España
Philips Respironics
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Closed envelop to be opened after inclusion/exclusion criteria are met and informed consent obtained
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline. | 1 hour | 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. |
| Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems. | 1 hour | 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. |
| Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system. | 1 hour | 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. |
| Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system. | 1 hour | 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. |
Countries
Spain
Outcome results
None listed