An interventional study of Change to VC/AC and Change in Tidal Volume in Respiratory Failure, Dyspnea During Mechanical Ventilation and Mechanical Ventilation, sponsored by Beth Israel Deaconess Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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/how 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)].
To 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/breathing 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.
Dyspnea 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".
Limited 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.
Dyspnea 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.
The 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.
Data 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/AC), 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.
For 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.
Data 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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to communicate/answer 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.
Physicians and nurses are trained to evaluate patients using both scales
Exclusion Criteria:
The intervention consists of changes in ventilator with evaluation of associated patient dyspnea. The sequence of interventions will include: * After consenting and explaining the procedures in details, baseline dyspnea will be obtained * All patients will be set on volume control/assist control (VC/AC) 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/AC will be kept on same settings. The investigators will check dyspnea after this initial change. * The following series of changes in mechanical ventilation will be instituted in a randomized sequence, lasting 3 minutes each: * Change in tidal volume * Change in inspiratory flow * Change in PEEP * Change to PSV to match their initial settings. * After every change the patient will rate dyspnea with an ordinal scale and Pocc and P01 will be assessed
Other: Change to VC/AC · Other: Change in Tidal Volume · Other: Change in inspiratory flow · Other: Change in PEEP · Other: Change to PSV
All patients will be set on volume control/assist control (VC/AC) 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/AC will be kept on same settings. The investigators will check dyspnea after this initial change.
Change in 2mL/kg (increase and/or 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).
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).
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).
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).
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. The investigators 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)
Time frame: 3 minutes after the change
Changes in dyspnea scales with change to VC/AC
Changes in dyspnea scales with change to VC/AC from original mode The investigators 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)
Time frame: 3 minutes after change
Change in respiratory drive measured by P0.1
Changes in P0.1 in cmH2O with each intervention/change in ventilator setting: Change in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC/AC with equivalent parameters
Time frame: 3 minutes after each change
Change in respiratory effort measured by Pocc
Changes in Pocc in cmH2O with each intervention/change in ventilator setting: Change in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC/AC with equivalent parameters
Time frame: 3 minutes after every change
Changes in P0.1/Pocc ratio
Changes in P0.1/Pocc with each intervention/change in ventilator setting: Change in tidal volume Change in inspiratory flow Change in PEEP Change to PSV to match their initial settings. Original mode to VC/AC with equivalent parameters
Time frame: 3 minutes after every change
Plan to share: Yes — De-identified individual participant data may be shared upon reasonable request and after approval by the study investigators and institutional review board, in accordance with institutional policies and participant privacy protections.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beth Israel Deaconess Medical Center →