Respiratory FailureNCT07701850
Mechanical Ventilator Adjustments and Patient Dyspnea
A study testing Change to VC/AC, Change in Tidal Volume and Change in inspiratory flow in people with Respiratory Failure and Dyspnea During Mechanical Ventilation, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Dyspnea During Mechanical Ventilation, Mechanical Ventilation
- What is being tested?
- Change to VC/AC, Change in Tidal Volume and Change in inspiratory flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Influence of Standard Ventilator Setting Adjustments on Dyspnea Experienced in Awake Mechanically-ventilated Patients: A Pilot Study
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.
Read the detailed description
For patients who develop acute respiratory failure, endotracheal tube (ETT) intubation and mechanical ventilation represent a potentially life-saving intervention to provide support for breathing and allow the opportunity for lungs to recover from critical illness. Current standard practice for mechanical ventilation varies, and includes selecting mechanical ventilator mode (including volume-cycled or pressure-cycled), and routine adjustments of ventilator settings [including settings such as flow rate, tidal volume (Vt), positive end-expiratory pressure (PEEP)].
To assess and confirm the choice of mechanical ventilator settings for each patient, current standard practice includes monitoring vital signs, lung mechanics, observed use of accessory respiratory/breathing muscles by the patient, non-invasive measurement of percent oxygen saturation of the blood (SpO2), and direct blood sample analysis (including arterial or venous blood gas tests). However, direct assessment of patient breathing comfort, or the presence of breathing discomfort (i.e. dyspnea), is not routinely performed in mechanically ventilated patients, and represents a significant knowledge gap.
Dyspnea is a common symptom in hospitalized patients, but the incidence, prevalence and severity of dyspnea in mechanically ventilated ICU patients is incompletely understood. Dyspnea is a common symptom among hospitalized patients. It is defined by American Thoracic Society as "a term used to characterize a subjective experience of breathing discomfort that consists of qualitative distinct sensations that may vary in intensity. The experience derives from interaction among multiple physiological, psychological, social and environmental factors, and may induce secondary physiological and behavioral responses".
Limited publications suggest that up to 50% of intubated patients experience moderate-to-severe dyspnea during ICU admission (data limited to patients who are able to communicate), and survivors of critical illness acute respiratory failure report post-traumatic stress disorder (PTSD), and dyspnea symptoms other mental health problems commonly associated with including nightmares and flashbacks.
Dyspnea assessment in intubated and mechanically ventilated patients represents a substantial challenge. For patients with acute critical illness requiring intubation and mechanical ventilation, treatment often also requires a heavy significant level of analgosedation to provide patient comfort, but while rendering the patient non-communicative.
The purpose of this protocol is to perform a pilot investigation, a prospective, single center, multiple ICU, randomized, blinded, clinical study to assess the impact of standard ventilator setting adjustments on breathing discomfort experienced by intubated patients recovering from acute respiratory failure. This study will focus on adults who remain intubated (endotracheal tube; ETT), mechanically ventilated, but are awake and can effectively communicate by non-verbal means.
Data collection will focus on assessment for the presence or absence of patient-reported dyspnea at baseline, and following transitioning to a standard mechanical ventilator mode (VC/AC), and then during various standard adjustments of mechanical ventilator settings (including tidal volume, PEEP, and oxygen flow rate). Adjustments for each setting will include a specified pre-determined number of adjustments that reflect standard-of-care, followed by an assessment of patient-reported dyspnea over the course of 3 minutes at each setting adjustment.
For the purposes of this study, randomization refers to the sequence of changes in ventilator settings for each patient. All ventilator adjustments will be performed in the presence of a physician and respiratory therapist. Dyspnea will be assessed using standard validated tools (including Dyspnea modified multidimensional scale, and Dyspnea Quality Scale). Data will be collected on standardized form. The pilot study plan to enroll a total of 20 patients over a period of 6 months, including patients receiving care in any one of the BIDMC intensive care units, and each patients will be evaluated over the course of "30 minutes to 2 hours" for the purposes of this protocol.
Data from this pilot study will improve understanding of dyspnea associated with intubation and mechanical ventilation, and inform on design of future studies focusing on the management of patients with acute respiratory failure and requiring intubation and mechanical ventilation.
- Being tested
- Change to VC/AC, Change in Tidal Volume, Change in inspiratory flow, Change in PEEP, Change to PSV
- Keywords
- respiratory failure, mechanical ventilation, dyspnea
- Medical subject headings
- Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change to VC/ACOther
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 VolumeOther
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 flowOther
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 PEEPOther
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 PSVOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Change to VC/AC; Other: Change in Tidal Volume; Other: Change in inspiratory flow; Other: Change in PEEP; Other: Change to PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 minutes after the change
Secondary outcomes (4)
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)
Measured: 3 minutes after change
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
Measured: 3 minutes after each change
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
Measured: 3 minutes after every change
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
Measured: 3 minutes after every change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias Baedorf Kassis, Beth Israel Deaconess Medical Center
- Investigators
- Elias Baedorf-Kassis, MD, Principal investigator, Beth Israel Deaconess Medical CenterRichard Schwartzstein, MD, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701850
- Sponsor's protocol ID
- 2026P000159
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared upon reasonable request and after approval by the study investigators and institutional review board, in accordance with institutional policies and participant privacy protections.
Publications
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.
PubMed 35739167Grush 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.
PubMed 40227090Raux 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.
PubMed 31719608Gentzler 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.
PubMed 30485121Spencer-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.
PubMed 28358594Demoule 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.
PubMed 38388984Simon 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.
PubMed 2508520Parshall 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.
PubMed 22336677Esteban 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.
PubMed 11790214Patel 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.
PubMed 26735627Worsham 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.
PubMed 33011205Stevens 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.
PubMed 29476798
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Standard Ventilator Setting Adjustments on Dyspnea Experienced in Awake Mechanically-ventilated Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07701850
- Acronym / sponsor ID
- 2026P000159
- Keywords
- respiratory failure, mechanical ventilation, dyspnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For patients who develop acute respiratory failure, endotracheal tube (ETT) intubation and mechanical ventilation represent a potentially life-saving intervention to provide support for breathing and allow the opportunity for lungs to recover from critical illness. Current standard practice for mechanical ventilation varies, and includes selecting mechanical ventilator mode (including volume-cycled or pressure-cycled), and routine adjustments of ventilator settings [including settings such as flow rate, tidal volume (Vt), positive end-expiratory pressure (PEEP)].
To assess and confirm the choice of mechanical ventilator settings for each patient, current standard practice includes monitoring vital signs, lung mechanics, observed use of accessory respiratory/breathing muscles by the patient, non-invasive measurement of percent oxygen saturation of the blood (SpO2), and direct blood sample analysis (including arterial or venous blood gas tests). However, direct assessment of patient breathing comfort, or the presence of breathing discomfort (i.e. dyspnea), is not routinely performed in mechanically ventilated patients, and represents a significant knowledge gap.
Dyspnea is a common symptom in hospitalized patients, but the incidence, prevalence and severity of dyspnea in mechanically ventilated ICU patients is incompletely understood. Dyspnea is a common symptom among hospitalized patients. It is defined by American Thoracic Society as "a term used to characterize a subjective experience of breathing discomfort that consists of qualitative distinct sensations that may vary in intensity. The experience derives from interaction among multiple physiological, psychological, social and environmental factors, and may induce secondary physiological and behavioral responses".
Limited publications suggest that up to 50% of intubated patients experience moderate-to-severe dyspnea during ICU admission (data limited to patients who are able to communicate), and survivors of critical illness acute respiratory failure report post-traumatic stress disorder (PTSD), and dyspnea symptoms other mental health problems commonly associated with including nightmares and flashbacks.
Dyspnea assessment in intubated and mechanically ventilated patients represents a substantial challenge. For patients with acute critical illness requiring intubation and mechanical ventilation, treatment often also requires a heavy significant level of analgosedation to provide patient comfort, but while rendering the patient non-communicative.
The purpose of this protocol is to perform a pilot investigation, a prospective, single center, multiple ICU, randomized, blinded, clinical study to assess the impact of standard ventilator setting adjustments on breathing discomfort experienced by intubated patients recovering from acute respiratory failure. This study will focus on adults who remain intubated (endotracheal tube; ETT), mechanically ventilated, but are awake and can effectively communicate by non-verbal means.
Data collection will focus on assessment for the presence or absence of patient-reported dyspnea at baseline, and following transitioning to a standard mechanical ventilator mode (VC/AC), and then during various standard adjustments of mechanical ventilator settings (including tidal volume, PEEP, and oxygen flow rate). Adjustments for each setting will include a specified pre-determined number of adjustments that reflect standard-of-care, followed by an assessment of patient-reported dyspnea over the course of 3 minutes at each setting adjustment.
For the purposes of this study, randomization refers to the sequence of changes in ventilator settings for each patient. All ventilator adjustments will be performed in the presence of a physician and respiratory therapist. Dyspnea will be assessed using standard validated tools (including Dyspnea modified multidimensional scale, and Dyspnea Quality Scale). Data will be collected on standardized form. The pilot study plan to enroll a total of 20 patients over a period of 6 months, including patients receiving care in any one of the BIDMC intensive care units, and each patients will be evaluated over the course of "30 minutes to 2 hours" for the purposes of this protocol.
Data from this pilot study will improve understanding of dyspnea associated with intubation and mechanical ventilation, and inform on design of future studies focusing on the management of patients with acute respiratory failure and requiring intubation and mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilator Changes | Experimental | Other: Change to VC/AC, Other: Change in Tidal Volume, Other: Change in inspiratory flow, Other: Change in PEEP, Other: Change to PSVThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Admitted to a participating ICU at BIDMC
- Requiring mechanical ventilation
- Awake by both of the following criteria
- RASS -2 to +2*
- CAM-ICU negative‡
Key exclusion criteria (17 listed)
- Age < 18 years old
- Comfort measures only
- Hemodynamic instability (MAP < 65 mmHg) or increasing requirement of vasopressor
- PEEP > 10 cmH2O
- FiO2 > 0.6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change to VC/ACAll 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. | Other | Mechanical Ventilator Changes |
| Change in Tidal VolumeChange 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). | Other | Mechanical Ventilator Changes |
| Change in inspiratory flowIncrease 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). | Other | Mechanical Ventilator Changes |
| Change in PEEPChange 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). | Other | Mechanical Ventilator Changes |
| Change to PSVChange 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). | Other | Mechanical Ventilator Changes |
Primary outcome
Change in dyspnea scale from baseline
Time frame: 3 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)
4 secondary outcomes
Changes in dyspnea scales with change to VC/AC
Time frame: 3 minutes after change
Change in respiratory drive measured by P0.1
Time frame: 3 minutes after each change
Change in respiratory effort measured by Pocc
Time frame: 3 minutes after every change
Changes in P0.1/Pocc ratio
Time frame: 3 minutes after every change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 35739167Al-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.
- Background: PubMed 40227090Grush 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.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared upon reasonable request and after approval by the study investigators and institutional review board, in accordance with institutional policies and participant privacy protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias Baedorf-Kassis, MD principal investigator
Beth Israel Deaconess Medical Center
Richard Schwartzstein, MD study director
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change to VC/AC, Change in Tidal Volume and Change in inspiratory flow in people with Respiratory Failure and Dyspnea During Mechanical Ventilation, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Goodspeed, MPH (6176328055, vgoodspe@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspnea scale from baseline (time frame: 3 minutes after the change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07701850, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.