Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

NCT03940118 | Completed

• 1 other identifier: 18/253-R_X
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Tube; Tracheostomy

Keywords

respiratory secretion suctioning; mechanical insufflation exsufflation; hypertonic saline; hyaluronic acid; critically ill; artificial airway

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Catheter secretion suctioning

ACTIVE COMPARATOR

Secretions are aspirated with a catheter at -120 to -150 mBar

Device: Catheter secretion suctioning

Secretion suctioning + hypertonic saline

EXPERIMENTAL

Hypertonic saline is nebulized prior to aspiration of secretions.

Combination Product: Secretion suctioning + hypertonic saline

Ins-exsufflation

EXPERIMENTAL

Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg

Device: Ins-exsufflation

Ins-exsufflation + Hypertonic Saline

EXPERIMENTAL

Mechanical insufflation-exsufflation and hypertonic saline

Combination Product: Ins-exsufflation + Hypertonic saline

Interventions

Catheter secretion suctioning DEVICE

Catheter secretion suctioning with prior nebulization of hypertonic saline

Catheter secretion suctioning

Secretion suctioning + hypertonic saline COMBINATION_PRODUCT

Catheter secretion suctioning with prior nebulization of hypertonic saline

Secretion suctioning + hypertonic saline

Ins-exsufflation DEVICE

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

Ins-exsufflation

Ins-exsufflation + Hypertonic saline COMBINATION_PRODUCT

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

Ins-exsufflation + Hypertonic Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.
• Need for aspiration of secretions
• Informed consent

You may not qualify if:

• Macroscopic hemoptysis.
• Acute bronchospasm
• Uncrontrolled muscular contractions, like tremor, myoclonus or other.
• Confirmed pregnancy

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Chiesi España: collaborator
• Philips Respironics: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (3)

• 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.

  PMID: 27590592 BACKGROUND

• 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.

  PMID: 12421743 BACKGROUND

• 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.

  PMID: 4835444 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Miguel Sanchez Garcia, MD, PhD

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Closed envelop to be opened after inclusion/exclusion criteria are met and informed consent obtained
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Critical Care. MD. PhD.

Model Details: 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

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: May 7, 2019
• Study Start: June 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

ES (1)