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Mechanical Ventilator Adjustments and Patient Dyspnea

ConditionsRespiratory FailureDyspnea During Mechanical VentilationMechanical Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to a participating ICU at BIDMC

Requiring mechanical ventilation

Awake by both of the following criteria

RASS -2 to +2*

Disqualifiers

Age < 18 years old

Comfort measures only

Hemodynamic instability (MAP < 65 mmHg) or increasing requirement of vasopressor

PEEP > 10 cmH2O

Trial design

Design model

Single group

Treatments tested in this trial

  • Change to VC/AC

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Mechanical Ventilator ChangesExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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. 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)

Time frame
3 minutes after the change

Secondary outcomes

1

Changes in dyspnea scales with change to VC/AC

Changes in dyspnea scales with change to VC/AC from original mode 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)

Time frame
3 minutes after change
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov

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