[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645481":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":40,"centralContacts":47,"locations":57,"responsibleParty":70,"collaborators":23,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":23,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":23,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":97,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanical Ventilator Changes","EXPERIMENTAL","The intervention consists of changes in ventilator with evaluation of associated patient dyspnea.\n\nThe sequence of interventions will include:\n\n* After consenting and explaining the procedures in details, baseline dyspnea will be obtained\n* All patients will be set on volume control\u002Fassist control (VC\u002FAC) with flow at ramp and appropriate settings to approximate their initial tidal volume, minute ventilation, respiratory rate, FiO2 and PEEP. This change is routinely performed in the ICU. Patients already on VC\u002FAC will be kept on same settings. The investigators will check dyspnea after this initial change.\n* The following series of changes in mechanical ventilation will be instituted in a randomized sequence, lasting 3 minutes each:\n\n  * Change in tidal volume\n  * Change in inspiratory flow\n  * Change in PEEP\n  * Change to PSV to match their initial settings.\n* After every change the patient will rate dyspnea with an ordinal scale and Pocc and P01 will be assessed",[13,14,15,16,17],"Other: Change to VC\u002FAC","Other: Change in Tidal Volume","Other: Change in inspiratory flow","Other: Change in PEEP","Other: Change to PSV",[19,24,28,32,36],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Change to VC\u002FAC","All patients will be set on volume control\u002Fassist control (VC\u002FAC) with flow at ramp and appropriate settings to approximate their initial tidal volume, minute ventilation, respiratory rate, FiO2 and PEEP. This change is routinely performed in the ICU. Patients already on VC\u002FAC will be kept on same settings. The investigators will check dyspnea after this initial change.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Change in Tidal Volume","Change in 2mL\u002Fkg (increase and\u002For decrease) for 3 minutes. After every change the patient will rate dyspnea with an ordinal scale and The investigators will assess occlusion pressure at the mouth at the onset of inspiration (P0.1 and Pocc).",[9],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Change in inspiratory flow","Increase in 25% of baseline flow for 3 minutes Decrease in 25% of baseline flow for 3 minutes After every change the patient will rate dyspnea with an ordinal scale and the investigators will assess occlusion pressure at the mouth at the onset of inspiration (P0.1 and Pocc).",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Change in PEEP","Change in PEEP by 5 cmH2O After every change the patient will rate dyspnea with an ordinal scale and the investigators will assess occlusion pressure at the mouth at the onset of inspiration (P0.1 and Pocc).",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":23},"Change to PSV","Change to PSV to match their initial settings. After every change the patient will rate dyspnea with an ordinal scale and The investigators will assess occlusion pressure at the mouth at the onset of inspiration (P0.1 and Pocc).",[9],[41,44],{"name":42,"affiliation":5,"role":43},"Elias Baedorf-Kassis, MD","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":5,"role":46},"Richard Schwartzstein, MD","STUDY_DIRECTOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":23,"email":52},"Valerie Goodspeed, MPH","CONTACT","6176328055","vgoodspe@bidmc.harvard.edu",{"name":54,"role":50,"phone":55,"phoneExt":23,"email":56},"Eduardo Padrao, MD","8603716289","epadrao@bidmc.harvard.edu",[58],{"facility":5,"status":23,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":23},"Boston","Massachusetts","02215","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-71.05977,42.35843,{"lat":68,"lon":67},{"type":43,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Elias Baedorf Kassis","MD","100645481","mechanical-ventilator-adjustments-and-patient-dyspnea-100645481",false,"NCT07701850","Mechanical Ventilator Adjustments and Patient Dyspnea","The Influence of Standard Ventilator Setting Adjustments on Dyspnea Experienced in Awake Mechanically-ventilated Patients: A Pilot Study","Inclusion Criteria:\n\n* Admitted to a participating ICU at BIDMC\n* Requiring mechanical ventilation\n* Awake by both of the following criteria\n* RASS -2 to +2\\*\n* CAM-ICU negative‡\n* Able to communicate\u002Fanswer dyspnea questionnaire\n\n  * RASS (Richmond Agitation-Sedation Scale) is a validated scale commonly used in the ICU to assess patient's level of sedation and agitation. It ranges from -5 to +4. While -5 means an unarousable coma, +4 means violent patient with immediate self danger. The scale from -2 to +2 ranges from light sedation to agitated.\n\n    * CAM-ICU (Confusion Assessment Method) is an ICU validated scale used to assess the presence of delirium. A negative CAM-ICU scale has good positive and negative predictive value to diagnose or exclude delirium.\n\nPhysicians and nurses are trained to evaluate patients using both scales\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Comfort measures only\n* Hemodynamic instability (MAP \\\u003C 65 mmHg) or increasing requirement of vasopressor\n* PEEP \\> 10 cmH2O\n* FiO2 \\> 0.6\n* Current Prone position\n* Current Pneumothorax\n* Bronchopleural fistula\n* Neuromuscular conditions that impair responding to the dyspnea scale or expression\n* Dementia\n* Prisoners\n* Pregnant women\n* Patients intubated and ventilated for less than 12 hours during the current ventilation episode\n* pH \\\u003C 7.20 or \\> 7.55\n* Presence of chest tube\n* Status post thoracotomy\n* Treating clinician refusal","ALL","18 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87],"NA","In the past 5 years, there are increasing data suggesting that patients treated with mechanical ventilation experience shortness of breath, despite appropriate sedation. This adverse experience is believed to contribute to the finding that up to 25% of patients who survive severe respiratory diseases experience mental health problems including post traumatic distress syndrome (PTSD). The purpose of this study is to evaluate if\u002Fhow sequential changes in the delivery of mechanical ventilation affect shortness of breath sensation in awake patients requiring mechanical ventilation. Improving the knowledge of the impact of the patient-ventilator interaction on shortness of breath sensation may lead to strategies to improve the comfort of non-sedated and sedated ventilated patients, and thereby reduce mental health sequelae in survivors of acute severe respiratory diseases The investigators hypothesize that current ventilator strategies, particularly reduced tidal volume (size of breath given by the ventilator) utilized in managing patients with severe respiratory diseases, contribute to shortness of breath in patients with increased drive to breathe. In this setting, some safe ventilator changes may improve or worsen the shortness of breath sensation in awake patients on mechanical ventilation.",[90,91,92],"Respiratory Failure","Dyspnea During Mechanical Ventilation","Mechanical Ventilation",[94,95,96],"respiratory failure","mechanical ventilation","dyspnea","NOT_YET_RECRUITING","2026-07-08",{"date":100,"type":101},"2026-07-14","ACTUAL",{"date":103,"type":84},"2026-09-01",{"date":105,"type":84},"2027-07-01",{"name":5,"class":6},1]