Mechanical Ventilator Adjustments and Patient Dyspnea

Conditions

• Dyspnea During Mechanical Ventilation
• Mechanical Ventilation
• Respiratory Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Change to VC/AC — OTHER
  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 Tidal Volume — OTHER
  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).
• Change in inspiratory flow — OTHER
  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 — OTHER
  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 — OTHER
  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).

Study Details

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.

Key Dates

First listed

Jul 14, 2026

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Jun 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Mechanical Ventilator Changes
  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

Primary Outcome Measure

Change in dyspnea scale from baseline [ Time Frame: 3 minutes after the change ]

Central Contacts

• Valerie Goodspeed, MPH
  6176328055
  [email protected]
• Eduardo Padrao, MD
  8603716289
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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