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Respiratory FailureLungs and breathing

What this study is

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.

What's being tested

  • Change to VC/AC

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

Official title
The Influence of Standard Ventilator Setting Adjustments on Dyspnea Experienced in Awake Mechanically-ventilated Patients: A Pilot Study
Sponsor
Beth Israel Deaconess Medical Center
Conditions
Respiratory Failure · Dyspnea During Mechanical Ventilation · Mechanical Ventilation
Enrolling
20 people
Starts
2026-12-01
Est. completion
2027-07-01
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗