Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

Tracheostomy Clinical Trial

— SMASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940118
• Other study ID #: 18/253-R_X
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Tube
• Tracheostomy

Intervention

Device:
• Catheter secretion suctioning
Catheter secretion suctioning with prior nebulization of hypertonic saline

Combination Product:
• Secretion suctioning + hypertonic saline
Catheter secretion suctioning with prior nebulization of hypertonic saline

Device:
• Ins-exsufflation
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Combination Product:
• Ins-exsufflation + Hypertonic saline
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Chiesi España, Philips Respironics

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Latorre-Marco I, Acevedo-Nuevo M, Solís-Muñoz M, Hernández-Sánchez L, López-López C, Sánchez-Sánchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-García R, Górgolas-Ortiz C, De la Figuera-Bayón J, Cavia-García 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. — View Citation

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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