Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-12 @ 5:03 PM
Study NCT ID:
NCT03940118
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2018-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-09', 'releaseDate': '2023-06-07'}, {'resetDate': '2024-07-31', 'releaseDate': '2024-02-16'}], 'estimatedResultsFirstSubmitDate': '2023-06-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Closed envelop to be opened after inclusion/exclusion criteria are met and informed consent obtained'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2018-12-30', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline.', 'timeFrame': '1 hour', 'description': 'Comparative incidence of aggregate hemodynamic and respiratory adverse events.\n\nAdverse events criteria are predefined and will be expressed as:\n\n* Percentage of patients meeting aggregate predefined hemodynamic or respiratory adverse event criteria per study group.\n* 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.'}, {'measure': 'Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems.', 'timeFrame': '1 hour', 'description': '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.\n\nBoth comparison of the score at the 4 study time-points and their variations between time-points will be analysed.'}, {'measure': 'Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.', 'timeFrame': '1 hour', 'description': '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.'}, {'measure': 'Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system.', 'timeFrame': '1 hour', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory secretion suctioning', 'mechanical insufflation exsufflation', 'hypertonic saline', 'hyaluronic acid', 'critically ill', 'artificial airway'], 'conditions': ['Endotracheal Tube', 'Tracheostomy']}, 'referencesModule': {'references': [{'pmid': '27590592', 'type': 'BACKGROUND', 'citation': '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': '12421743', 'type': 'BACKGROUND', 'citation': "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': '4835444', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMechanical 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.', 'detailedDescription': '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.\n\nMechanical 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.\n\nOnly anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available.\n\nBackground: 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.\n* Need for aspiration of secretions\n* Informed consent\n\nExclusion Criteria:\n\n* Macroscopic hemoptysis.\n* Acute bronchospasm\n* Uncrontrolled muscular contractions, like tremor, myoclonus or other.\n* Confirmed pregnancy'}, 'identificationModule': {'nctId': 'NCT03940118', 'acronym': 'SMASH', 'briefTitle': 'Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '18/253-R_X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Catheter secretion suctioning', 'description': 'Secretions are aspirated with a catheter at -120 to -150 mBar', 'interventionNames': ['Device: Catheter secretion suctioning']}, {'type': 'EXPERIMENTAL', 'label': 'Secretion suctioning + hypertonic saline', 'description': 'Hypertonic saline is nebulized prior to aspiration of secretions.', 'interventionNames': ['Combination Product: Secretion suctioning + hypertonic saline']}, {'type': 'EXPERIMENTAL', 'label': 'Ins-exsufflation', 'description': 'Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg', 'interventionNames': ['Device: Ins-exsufflation']}, {'type': 'EXPERIMENTAL', 'label': 'Ins-exsufflation + Hypertonic Saline', 'description': 'Mechanical insufflation-exsufflation and hypertonic saline', 'interventionNames': ['Combination Product: Ins-exsufflation + Hypertonic saline']}], 'interventions': [{'name': 'Catheter secretion suctioning', 'type': 'DEVICE', 'description': 'Catheter secretion suctioning with prior nebulization of hypertonic saline', 'armGroupLabels': ['Catheter secretion suctioning']}, {'name': 'Secretion suctioning + hypertonic saline', 'type': 'COMBINATION_PRODUCT', 'description': 'Catheter secretion suctioning with prior nebulization of hypertonic saline', 'armGroupLabels': ['Secretion suctioning + hypertonic saline']}, {'name': 'Ins-exsufflation', 'type': 'DEVICE', 'description': 'Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning', 'armGroupLabels': ['Ins-exsufflation']}, {'name': 'Ins-exsufflation + Hypertonic saline', 'type': 'COMBINATION_PRODUCT', 'description': 'Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning', 'armGroupLabels': ['Ins-exsufflation + Hypertonic Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Miguel Sanchez Garcia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico San Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chiesi España', 'class': 'UNKNOWN'}, {'name': 'Philips Respironics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Critical Care. MD. PhD.', 'investigatorFullName': 'Miguel Sanchez Garcia', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-07', 'type': 'RELEASE'}, {'date': '2024-02-09', 'type': 'RESET'}, {'date': '2024-02-16', 'type': 'RELEASE'}, {'date': '2024-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Miguel Sanchez Garcia, Director Critical Care. MD. PhD., Hospital San Carlos, Madrid'}}}}