[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07701850":3,"trial-entities:NCT07701850":176,"trial-summary:NCT07701850":179},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":55,"secondary_outcomes":60,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":108,"locations":111,"central_contacts":120,"overall_officials":130,"references":137,"see_also_links":175},"NCT07701850","2026P000159","Mechanical Ventilator Adjustments and Patient Dyspnea","The Influence of Standard Ventilator Setting Adjustments on Dyspnea Experienced in Awake Mechanically-ventilated Patients: A Pilot Study","NOT_YET_RECRUITING","2027-07-01","2026-06","2026-07-14","2026-09-01","Beth Israel Deaconess Medical Center","OTHER",false,"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.","For patients who develop acute respiratory failure, endotracheal tube (ETT) intubation and mechanical ventilation represent a potentially life-saving intervention to provide support for breathing and allow the opportunity for lungs to recover from critical illness. Current standard practice for mechanical ventilation varies, and includes selecting mechanical ventilator mode (including volume-cycled or pressure-cycled), and routine adjustments of ventilator settings \\[including settings such as flow rate, tidal volume (Vt), positive end-expiratory pressure (PEEP)\\].\n\nTo assess and confirm the choice of mechanical ventilator settings for each patient, current standard practice includes monitoring vital signs, lung mechanics, observed use of accessory respiratory\u002Fbreathing muscles by the patient, non-invasive measurement of percent oxygen saturation of the blood (SpO2), and direct blood sample analysis (including arterial or venous blood gas tests). However, direct assessment of patient breathing comfort, or the presence of breathing discomfort (i.e. dyspnea), is not routinely performed in mechanically ventilated patients, and represents a significant knowledge gap.\n\nDyspnea is a common symptom in hospitalized patients, but the incidence, prevalence and severity of dyspnea in mechanically ventilated ICU patients is incompletely understood. Dyspnea is a common symptom among hospitalized patients. It is defined by American Thoracic Society as \"a term used to characterize a subjective experience of breathing discomfort that consists of qualitative distinct sensations that may vary in intensity. The experience derives from interaction among multiple physiological, psychological, social and environmental factors, and may induce secondary physiological and behavioral responses\".\n\nLimited publications suggest that up to 50% of intubated patients experience moderate-to-severe dyspnea during ICU admission (data limited to patients who are able to communicate), and survivors of critical illness acute respiratory failure report post-traumatic stress disorder (PTSD), and dyspnea symptoms other mental health problems commonly associated with including nightmares and flashbacks.\n\nDyspnea assessment in intubated and mechanically ventilated patients represents a substantial challenge. For patients with acute critical illness requiring intubation and mechanical ventilation, treatment often also requires a heavy significant level of analgosedation to provide patient comfort, but while rendering the patient non-communicative.\n\nThe purpose of this protocol is to perform a pilot investigation, a prospective, single center, multiple ICU, randomized, blinded, clinical study to assess the impact of standard ventilator setting adjustments on breathing discomfort experienced by intubated patients recovering from acute respiratory failure. This study will focus on adults who remain intubated (endotracheal tube; ETT), mechanically ventilated, but are awake and can effectively communicate by non-verbal means.\n\nData collection will focus on assessment for the presence or absence of patient-reported dyspnea at baseline, and following transitioning to a standard mechanical ventilator mode (VC\u002FAC), and then during various standard adjustments of mechanical ventilator settings (including tidal volume, PEEP, and oxygen flow rate). Adjustments for each setting will include a specified pre-determined number of adjustments that reflect standard-of-care, followed by an assessment of patient-reported dyspnea over the course of 3 minutes at each setting adjustment.\n\nFor the purposes of this study, randomization refers to the sequence of changes in ventilator settings for each patient. All ventilator adjustments will be performed in the presence of a physician and respiratory therapist. Dyspnea will be assessed using standard validated tools (including Dyspnea modified multidimensional scale, and Dyspnea Quality Scale). Data will be collected on standardized form. The pilot study plan to enroll a total of 20 patients over a period of 6 months, including patients receiving care in any one of the BIDMC intensive care units, and each patients will be evaluated over the course of \"30 minutes to 2 hours\" for the purposes of this protocol.\n\nData from this pilot study will improve understanding of dyspnea associated with intubation and mechanical ventilation, and inform on design of future studies focusing on the management of patients with acute respiratory failure and requiring intubation and mechanical ventilation.",[19,20,21],"Respiratory Failure","Dyspnea During Mechanical Ventilation","Mechanical Ventilation",[23,24,25],"respiratory failure","mechanical ventilation","dyspnea","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34,39,43,47,51],{"type":14,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"Mechanical Ventilator Changes",{"type":14,"name":40,"description":41,"armGroupLabels":42},"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).",[38],{"type":14,"name":44,"description":45,"armGroupLabels":46},"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).",[38],{"type":14,"name":48,"description":49,"armGroupLabels":50},"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).",[38],{"type":14,"name":52,"description":53,"armGroupLabels":54},"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).",[38],[56],{"measure":57,"description":58,"timeFrame":59},"Change in dyspnea scale from baseline","Change in dyspnea scale when changing the following settings Increase and decrease in tidal volume Increase, decrease in flow and change in flow curve Changes in PEEP Change to PSV to match their initial settings.\n\nWe will use a modified multidimensional dyspnea scale, which includes from pleasant, neutral, slight sensation, annoying, distressing and unbearable. It also includes sensory qualities which ranges from 1 to 5 (5 being worse)","3 minutes after the change",[61,65,69,73],{"measure":62,"description":63,"timeFrame":64},"Changes in dyspnea scales with change to VC\u002FAC","Changes in dyspnea scales with change to VC\u002FAC from original mode\n\nWe will use a modified multidimensional dyspnea scale, which includes from pleasant, neutral, slight sensation, annoying, distressing and unbearable. It also includes sensory qualities which ranges from 1 to 5 (5 being worse)","3 minutes after change",{"measure":66,"description":67,"timeFrame":68},"Change in respiratory drive measured by P0.1","Changes in P0.1 in cmH2O with each intervention\u002Fchange in ventilator setting:\n\nChange in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC\u002FAC with equivalent parameters","3 minutes after each change",{"measure":70,"description":71,"timeFrame":72},"Change in respiratory effort measured by Pocc","Changes in Pocc in cmH2O with each intervention\u002Fchange in ventilator setting:\n\nChange in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC\u002FAC with equivalent parameters","3 minutes after every change",{"measure":74,"description":75,"timeFrame":72},"Changes in P0.1\u002FPocc ratio","Changes in P0.1\u002FPocc with each intervention\u002Fchange in ventilator setting:\n\nChange in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC\u002FAC with equivalent parameters","ALL","18 Years",null,{"inclusion":80,"exclusion":89,"raw_text":107},[81,82,83,84,85,86,87,88],"Admitted to a participating ICU at BIDMC","Requiring mechanical ventilation","Awake by both of the following criteria","RASS -2 to +2\\*","CAM-ICU negative‡","Able to communicate\u002Fanswer dyspnea questionnaire","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.","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.",[90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Age \\\u003C 18 years old","Comfort measures only","Hemodynamic instability (MAP \\\u003C 65 mmHg) or increasing requirement of vasopressor","PEEP \\> 10 cmH2O","FiO2 \\> 0.6","Current Prone position","Current Pneumothorax","Bronchopleural fistula","Neuromuscular conditions that impair responding to the dyspnea scale or expression","Dementia","Prisoners","Pregnant women","Patients intubated and ventilated for less than 12 hours during the current ventilation episode","pH \\\u003C 7.20 or \\> 7.55","Presence of chest tube","Status post thoracotomy","Treating clinician refusal","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",[109,110],"ADULT","OLDER_ADULT",[112],{"facility":13,"city":113,"state":114,"zip":115,"country":116,"geoPoint":117},"Boston","Massachusetts","02215","United States",{"lat":118,"lon":119},42.35843,-71.05977,[121,126],{"name":122,"role":123,"phone":124,"email":125},"Valerie Goodspeed, MPH","CONTACT","6176328055","vgoodspe@bidmc.harvard.edu",{"name":127,"role":123,"phone":128,"email":129},"Eduardo Padrao, MD","8603716289","epadrao@bidmc.harvard.edu",[131,134],{"name":132,"affiliation":13,"role":133},"Elias Baedorf-Kassis, MD","PRINCIPAL_INVESTIGATOR",{"name":135,"affiliation":13,"role":136},"Richard Schwartzstein, MD","STUDY_DIRECTOR",[138,142,145,148,151,154,157,160,163,166,169,172],{"pmid":139,"type":140,"citation":141},"35739167","BACKGROUND","Al-Thani H, Al-Hassani A, El-Menyar A, Asim M, Fawzy I. Outcome of post-traumatic acute respiratory distress syndrome in young patients requiring extracorporeal membrane oxygenation (ECMO). Sci Rep. 2022 Jun 23;12(1):10609. doi: 10.1038\u002Fs41598-022-14741-6.",{"pmid":143,"type":140,"citation":144},"40227090","Grush KA, Svoboda E, Dunbar PJ, Kannappan A, Perrodin J, Root MZ, Mikkelsen ME. Dyspnea Among Mechanically Ventilated Patients: A Systematic Review. Crit Care Med. 2025 Jun 1;53(6):e1282-e1291. doi: 10.1097\u002FCCM.0000000000006664. Epub 2025 Apr 14.",{"pmid":146,"type":140,"citation":147},"31719608","Raux M, Navarro-Sune X, Wattiez N, Kindler F, Le Corre M, Decavele M, Demiri S, Demoule A, Chavez M, Similowski T. Adjusting ventilator settings to relieve dyspnoea modifies brain activity in critically ill patients: an electroencephalogram pilot study. Sci Rep. 2019 Nov 12;9(1):16572. doi: 10.1038\u002Fs41598-019-53152-y.",{"pmid":149,"type":140,"citation":150},"30485121","Gentzler ER, Derry H, Ouyang DJ, Lief L, Berlin DA, Xu CJ, Maciejewski PK, Prigerson HG. Underdetection and Undertreatment of Dyspnea in Critically Ill Patients. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1377-1384. doi: 10.1164\u002Frccm.201805-0996OC.",{"pmid":152,"type":140,"citation":153},"28358594","Spencer-Segal JL, Hyzy RC, Iwashyna TJ, Standiford TJ. Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation. Ann Am Thorac Soc. 2017 Jun;14(6):960-967. doi: 10.1513\u002FAnnalsATS.201606-468OC.",{"pmid":155,"type":140,"citation":156},"38388984","Demoule A, Decavele M, Antonelli M, Camporota L, Abroug F, Adler D, Azoulay E, Basoglu M, Campbell M, Grasselli G, Herridge M, Johnson MJ, Naccache L, Navalesi P, Pelosi P, Schwartzstein R, Williams C, Windisch W, Heunks L, Similowski T. Dyspnoea in acutely ill mechanically ventilated adult patients: an ERS\u002FESICM statement. Intensive Care Med. 2024 Feb;50(2):159-180. doi: 10.1007\u002Fs00134-023-07246-x. Epub 2024 Feb 22.",{"pmid":158,"type":140,"citation":159},"2508520","Simon PM, Schwartzstein RM, Weiss JW, Lahive K, Fencl V, Teghtsoonian M, Weinberger SE. Distinguishable sensations of breathlessness induced in normal volunteers. Am Rev Respir Dis. 1989 Oct;140(4):1021-7. doi: 10.1164\u002Fajrccm\u002F140.4.1021.",{"pmid":161,"type":140,"citation":162},"22336677","Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164\u002Frccm.201111-2042ST.",{"pmid":164,"type":140,"citation":165},"11790214","Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001\u002Fjama.287.3.345.",{"pmid":167,"type":140,"citation":168},"26735627","Patel MB, Jackson JC, Morandi A, Girard TD, Hughes CG, Thompson JL, Kiehl AL, Elstad MR, Wasserstein ML, Goodman RB, Beckham JC, Chandrasekhar R, Dittus RS, Ely EW, Pandharipande PP. Incidence and Risk Factors for Intensive Care Unit-related Post-traumatic Stress Disorder in Veterans and Civilians. Am J Respir Crit Care Med. 2016 Jun 15;193(12):1373-81. doi: 10.1164\u002Frccm.201506-1158OC.",{"pmid":170,"type":140,"citation":171},"33011205","Worsham CM, Banzett RB, Schwartzstein RM. Dyspnea, Acute Respiratory Failure, Psychological Trauma, and Post-ICU Mental Health: A Caution and a Call for Research. Chest. 2021 Feb;159(2):749-756. doi: 10.1016\u002Fj.chest.2020.09.251. Epub 2020 Oct 1.",{"pmid":173,"type":140,"citation":174},"29476798","Stevens JP, Dechen T, Schwartzstein R, O'Donnell C, Baker K, Howell MD, Banzett RB. Prevalence of Dyspnea Among Hospitalized Patients at the Time of Admission. J Pain Symptom Manage. 2018 Jul;56(1):15-22.e2. doi: 10.1016\u002Fj.jpainsymman.2018.02.013. Epub 2018 Feb 22.",[],{"nct_id":4,"conditions":177,"biomarkers":178},[20,21,19],[],{"nct_id":4,"found":180,"summary":181,"prompt_version":191},true,{"design":182,"status":183,"heading":184,"summary":185,"follow_up":186,"word_count":187,"commitments":188,"compensation":189,"drugs_mentioned":190},"This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.","completed","Mechanical Ventilator Adjustments and Patient Dyspnea Study","This study is looking at how changes to mechanical ventilator settings affect shortness of breath (dyspnea) in awake patients who need breathing support. Researchers will adjust your ventilator settings, such as tidal volume (the amount of air you breathe in and out), inspiratory flow (how fast air goes into your lungs), and PEEP (positive end-expiratory pressure, which keeps your airways open). They will also try different ventilator modes like VC\u002FAC (volume control\u002Fassist control) and PSV (pressure support ventilation). After each change, you will be asked to rate your shortness of breath. The goal is to understand if these adjustments can make breathing more comfortable for patients on ventilators. This study is for patients aged 18 and older who are in the ICU, on a ventilator, awake, and able to communicate.","Your dyspnea will be measured at 3 minutes after each change in ventilator settings.",130,"You would have your ventilator settings adjusted for short periods (3 minutes per change). After each adjustment, you would rate your shortness of breath.","Not stated in the trial record.",[],"v2"]