Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline
NCT ID: NCT03940118
Last Updated: 2019-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-06-01
2019-04-30
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
SINGLE
Study Groups
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Catheter secretion suctioning
Secretions are aspirated with a catheter at -120 to -150 mBar
Catheter secretion suctioning
Catheter secretion suctioning with prior nebulization of hypertonic saline
Secretion suctioning + hypertonic saline
Hypertonic saline is nebulized prior to aspiration of secretions.
Secretion suctioning + hypertonic saline
Catheter secretion suctioning with prior nebulization of hypertonic saline
Ins-exsufflation
Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg
Ins-exsufflation
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Ins-exsufflation + Hypertonic Saline
Mechanical insufflation-exsufflation and hypertonic saline
Ins-exsufflation + Hypertonic saline
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Interventions
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Catheter secretion suctioning
Catheter secretion suctioning with prior nebulization of hypertonic saline
Secretion suctioning + hypertonic saline
Catheter secretion suctioning with prior nebulization of hypertonic saline
Ins-exsufflation
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Ins-exsufflation + Hypertonic saline
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Eligibility Criteria
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Inclusion Criteria
* Need for aspiration of secretions
* Informed consent
Exclusion Criteria
* Acute bronchospasm
* Uncrontrolled muscular contractions, like tremor, myoclonus or other.
* Confirmed pregnancy
18 Years
ALL
No
Sponsors
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Chiesi España
UNKNOWN
Philips Respironics
INDUSTRY
Hospital San Carlos, Madrid
OTHER
Responsible Party
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Miguel Sanchez Garcia
Director Critical Care. MD. PhD.
Principal Investigators
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Miguel Sanchez Garcia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico San Carlos
Locations
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Hospital Clinico San Carlos
Madrid, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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18/253-R_X
Identifier Type: -
Identifier Source: org_study_id
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