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/AC (volume control/assist 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.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would have your ventilator settings adjusted for short periods (3 minutes per change). After each adjustment, you would rate your shortness of breath.
Compensation
Not stated in the trial record.
Follow-up
Your dyspnea will be measured at 3 minutes after each change in ventilator settings.

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NCT07701850

Mechanical Ventilator Adjustments and Patient Dyspnea

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Beth Israel Deaconess Medical Center
~20 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Change to VC/ACChange in Tidal VolumeChange in inspiratory flowChange in PEEPChange to PSV

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in dyspnea scale from baseline
Measured over 3 minutes after the change
Respiratory Failure
Dyspnea During Mechanical Ventilation
Mechanical Ventilation
1 sites across 1 states
Massachusetts1
  • Elias Baedorf-Kassis, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
  • Richard Schwartzstein, MD · STUDY_DIRECTOR · Beth Israel Deaconess Medical Center

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Eligibility criteria

Inclusion

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/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.
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.

Exclusion

Age \< 18 years old
Comfort measures only
Hemodynamic instability (MAP \< 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 \< 7.20 or \> 7.55
Presence of chest tube
Status post thoracotomy
Treating clinician refusal
  • Change in dyspnea scale from baseline3 minutes after the change

    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. We 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)