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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

Clinicaltrials.gov identifier NCT03940118

Recruitment Status Completed

First Posted May 7, 2019

Last update posted May 8, 2019

Study Description

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.

  • Condition or Disease:Endotracheal Tube
    Tracheostomy
  • Intervention/Treatment: Device: Catheter secretion suctioning
    Combination Product: Secretion suctioning + hypertonic saline
    Device: Ins-exsufflation
    Combination Product: Ins-exsufflation + Hypertonic saline
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • 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
  • Masking: Single (Investigator)
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: June 2018
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

Spain
Hospital Clinico San Carlos
Madrid

Sponsors and Collaborators

Hospital San Carlos, Madrid

Chiesi España

Philips Respironics

Investigators

Principal Investigator: Miguel Sanchez Garcia, MD, PhD Hospital Clinico San Carlos