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| Name | Class |
|---|---|
| Chiesi España | UNKNOWN |
| Philips Respironics | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter secretion suctioning | Active Comparator | Secretions are aspirated with a catheter at -120 to -150 mBar |
|
| Secretion suctioning + hypertonic saline | Experimental | Hypertonic saline is nebulized prior to aspiration of secretions. |
|
| Ins-exsufflation | Experimental | Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg |
|
| Ins-exsufflation + Hypertonic Saline | Experimental | Mechanical insufflation-exsufflation and hypertonic saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter secretion suctioning | Device | Catheter secretion suctioning with prior nebulization of hypertonic saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Sanchez Garcia, MD, PhD | Hospital Clinico San Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27590592 | 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. | |
| 12421743 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 7, 2023 | |
| Reset | Feb 9, 2024 | |
| Release | Feb 16, 2024 | |
| Reset | Jul 31, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 7, 2023 | Feb 9, 2024 | |||
| Feb 16, 2024 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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
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Closed envelop to be opened after inclusion/exclusion criteria are met and informed consent obtained
| 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 |
|
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 |
| 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. |
| 4835444 | 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. |
| Jul 31, 2024 |