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Completed

NCT Number: NCT03940118

Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

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.

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Key information

Conditions

Endotracheal Tube Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter secretion suctioning

Device

Catheter secretion suctioning with prior nebulization of hypertonic saline

Secretion suctioning + hypertonic saline

Combination Product

Catheter secretion suctioning with prior nebulization of hypertonic saline

Ins-exsufflation

Device

Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Ins-exsufflation + Hypertonic saline

Combination Product

Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Primary outcomes

  1. Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline.

    Time frame: 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.

  2. Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems.

    Time frame: 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.

  3. Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.

    Time frame: 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.

  4. Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Chiesi España
  • Philips Respironics

Registry information

Official study 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

Acronym: SMASH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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