Mechanical Ventilator Adjustments and Patient Dyspnea

NCT07701850 | Not Yet Recruiting

• 1 other identifier: 2026P000159
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure; Dyspnea During Mechanical Ventilation; Mechanical Ventilation

Keywords

respiratory failure; mechanical ventilation; dyspnea

Outcome Measures

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)

  3 minutes after the change

Secondary Outcomes (4)

• Changes in dyspnea scales with change to VC/AC

  3 minutes after change

• Change in respiratory drive measured by P0.1

  3 minutes after each change

• Change in respiratory effort measured by Pocc

  3 minutes after every change

• Changes in P0.1/Pocc ratio

  3 minutes after every change

Study Arms (1)

Mechanical Ventilator Changes

EXPERIMENTAL

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

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.

Mechanical Ventilator Changes

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).

Mechanical Ventilator Changes

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).

Mechanical Ventilator Changes

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).

Mechanical Ventilator Changes

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).

Mechanical Ventilator Changes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Physicians and nurses are trained to evaluate patients using both scales

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (12)

• Al-Thani H, Al-Hassani A, El-Menyar A, Asim M, Fawzy I. Outcome of post-traumatic acute respiratory distress syndrome in young patients requiring extracorporeal membrane oxygenation (ECMO). Sci Rep. 2022 Jun 23;12(1):10609. doi: 10.1038/s41598-022-14741-6.

  PMID: 35739167 BACKGROUND

• Grush KA, Svoboda E, Dunbar PJ, Kannappan A, Perrodin J, Root MZ, Mikkelsen ME. Dyspnea Among Mechanically Ventilated Patients: A Systematic Review. Crit Care Med. 2025 Jun 1;53(6):e1282-e1291. doi: 10.1097/CCM.0000000000006664. Epub 2025 Apr 14.

  PMID: 40227090 BACKGROUND

• Raux M, Navarro-Sune X, Wattiez N, Kindler F, Le Corre M, Decavele M, Demiri S, Demoule A, Chavez M, Similowski T. Adjusting ventilator settings to relieve dyspnoea modifies brain activity in critically ill patients: an electroencephalogram pilot study. Sci Rep. 2019 Nov 12;9(1):16572. doi: 10.1038/s41598-019-53152-y.

  PMID: 31719608 BACKGROUND

• Gentzler ER, Derry H, Ouyang DJ, Lief L, Berlin DA, Xu CJ, Maciejewski PK, Prigerson HG. Underdetection and Undertreatment of Dyspnea in Critically Ill Patients. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1377-1384. doi: 10.1164/rccm.201805-0996OC.

  PMID: 30485121 BACKGROUND

• Spencer-Segal JL, Hyzy RC, Iwashyna TJ, Standiford TJ. Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation. Ann Am Thorac Soc. 2017 Jun;14(6):960-967. doi: 10.1513/AnnalsATS.201606-468OC.

  PMID: 28358594 BACKGROUND

• Demoule A, Decavele M, Antonelli M, Camporota L, Abroug F, Adler D, Azoulay E, Basoglu M, Campbell M, Grasselli G, Herridge M, Johnson MJ, Naccache L, Navalesi P, Pelosi P, Schwartzstein R, Williams C, Windisch W, Heunks L, Similowski T. Dyspnoea in acutely ill mechanically ventilated adult patients: an ERS/ESICM statement. Intensive Care Med. 2024 Feb;50(2):159-180. doi: 10.1007/s00134-023-07246-x. Epub 2024 Feb 22.

  PMID: 38388984 BACKGROUND

• Simon PM, Schwartzstein RM, Weiss JW, Lahive K, Fencl V, Teghtsoonian M, Weinberger SE. Distinguishable sensations of breathlessness induced in normal volunteers. Am Rev Respir Dis. 1989 Oct;140(4):1021-7. doi: 10.1164/ajrccm/140.4.1021.

  PMID: 2508520 BACKGROUND

• Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

  PMID: 22336677 BACKGROUND

• Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  PMID: 11790214 BACKGROUND

• Patel MB, Jackson JC, Morandi A, Girard TD, Hughes CG, Thompson JL, Kiehl AL, Elstad MR, Wasserstein ML, Goodman RB, Beckham JC, Chandrasekhar R, Dittus RS, Ely EW, Pandharipande PP. Incidence and Risk Factors for Intensive Care Unit-related Post-traumatic Stress Disorder in Veterans and Civilians. Am J Respir Crit Care Med. 2016 Jun 15;193(12):1373-81. doi: 10.1164/rccm.201506-1158OC.

  PMID: 26735627 BACKGROUND

• Worsham CM, Banzett RB, Schwartzstein RM. Dyspnea, Acute Respiratory Failure, Psychological Trauma, and Post-ICU Mental Health: A Caution and a Call for Research. Chest. 2021 Feb;159(2):749-756. doi: 10.1016/j.chest.2020.09.251. Epub 2020 Oct 1.

  PMID: 33011205 BACKGROUND

• Stevens JP, Dechen T, Schwartzstein R, O'Donnell C, Baker K, Howell MD, Banzett RB. Prevalence of Dyspnea Among Hospitalized Patients at the Time of Admission. J Pain Symptom Manage. 2018 Jul;56(1):15-22.e2. doi: 10.1016/j.jpainsymman.2018.02.013. Epub 2018 Feb 22.

  PMID: 29476798 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Dyspnea

Interventions

Tidal Volume; Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Elias Baedorf-Kassis, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Richard Schwartzstein, MD

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Central Study Contacts

Valerie Goodspeed, MPH

CONTACT

6176328055; vgoodspe@bidmc.harvard.edu

Eduardo Padrao, MD

CONTACT

8603716289; epadrao@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be unaware of the nature of the changes in ventilator, the researcher obtaining the ratings and analyzing the data will be blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The intervention consists of changes in ventilator settings with evaluation of associated patient rated dyspnea. The sequence of interventions will include: * After consenting and explaining the procedures in details, the investigator will obtain baseline dyspnea. * 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 investigator will check dyspnea after 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 dyspnea will be rated with an ordinal scale and the investigat will assess Pocc and P01

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)