drugset / Trial / NCT03940118
Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline
Completed
120 enrolled
Hospital San Carlos, Madrid
Chiesi España · collabPhilips Respironics · collab
RandomizedFactorialSingle-blindOther
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.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
Publications
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hypertonic saline | Unknown | — | Inhaled |