Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline (SMASH)

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

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy; Endotracheal Tube
• Intervention / Treatment: Device: Catheter secretion suctioning; Combination product: Secretion suctioning + hypertonic saline; Device: Ins-exsufflation; Combination product: Ins-exsufflation + Hypertonic saline

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).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Collaborators: Philips Respironics; Chiesi España
• Investigators: Principal Investigator: Miguel Sanchez Garcia, MD, PhD, Hospital Clinico San Carlos

Publications and helpful links

General Publications

• Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
• Latorre-Marco I, Acevedo-Nuevo M, Solis-Munoz M, Hernandez-Sanchez L, Lopez-Lopez C, Sanchez-Sanchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-Garcia R, Gorgolas-Ortiz C, De la Figuera-Bayon J, Cavia-Garcia C. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients. Med Intensiva. 2016 Nov;40(8):463-473. doi: 10.1016/j.medin.2016.06.004. Epub 2016 Aug 31. English, Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: critically ill; hypertonic saline; hyaluronic acid; respiratory secretion suctioning; mechanical insufflation exsufflation; artificial airway
• Other Study ID Numbers: 18/253-R_X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No