Vascular ARDS Recruitment After Inhaled Nitric Oxide

Regional Vascular Recruitment With Inhaled Nitric Oxide in Patients With ARDS

Acute respiratory distress syndrome (ARDS) is when a person's lungs become inflamed, which can be caused by infection, trauma, surgery, blood transfusion, or burn. ARDS often leads to a situation where the person cannot breathe independently and needs machines' help. Once the lungs are inflamed, the small air sacs responsible for exchanging gases (i.e., ventilation) and the blood flow in the lungs (i.e., perfusion) can be affected. In the past, most research focused on studying ventilation physiology and how to help people breathe with machines. Less was done on perfusion because it requires imaging techniques such as computed tomography with intravenous contrast and radiation. One treatment option for low oxygen levels is inhaled nitric oxide (iNO), a gas that can dilate the lung blood vessels and improve oxygenation; however, it is not always clear whether this treatment will work.

Prone position has been used for several years in the care of ARDS patients and has been demonstrated to improve survival in more severe patients. It is not known how iNO and prone positioning interact in determining the distribution of pulmonary perfusion and whether their combine use can benefit ARDS patients.

Electrical Impedance Tomography (EIT) is a bedside and accessible imaging technique that is radiation-free and non-invasive and can potentially detect changes in lung perfusion. EIT can perform multiple measurements; it is portable and accessible. This prospective interventional study aims to assess changes in regional blood perfusion in the lungs of patients with ARDS in response to iNO and to prone positioning utilizing EIT. The main questions it aims to answer are:

1. If EIT can measure lung regional perfusion response to an iNO challenge of 20ppm for 15 minutes.
2. If EIT can measure the lung regional perfusion responses to prone position, applied alone and in combination with iNO.
3. If EIT is comparable to dual-energy computed tomography (DECT), the gold-standard method, in the detection of changes in regional lung perfusion due to iNO.
4. If EIT can be an imaging marker to identify ARDS severity

Participants will be divided into three cohorts:

1. Sub-Cohort 1 (n=60): Participants will be asked to be monitored by EIT before, during, and after the administration of iNO (20 ppm) for 15 minutes (OFF-ON-OFF) in the supine position
2. Sub-Cohort 2 (N=10): Participants will be asked to be monitored by EIT before and during the administration of iNO (20 ppm) for 15 minutes (OFF-ON) in both the supine and in the prone position. The same subjects will be monitored also with DECT in the supine position and then after 30 minutes in the prone position (without NO administration).
3. Sub-Cohort 3 (N=10): In this subset of Sub-Cohort 1, subjects will be asked to be monitored also with DECT (in addition to EIT) in the supine body position before iNO and after 15 minutes while receiving iNO.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Ventilation Perfusion Mismatch
• Intervention / Treatment: Device: Nitric Oxide

Detailed Description

The investigators will screen patients with ARDS diagnosis daily at MGH intensive care units and work in the consenting process with the ICU team and surrogates. The enrollment period will be limited to the time subjects will undergo the study procedures. Subjects will exit the study as soon as the study procedures are completed. No further procedures are planned; therefore, subjects will not be asked to return to the hospital exclusively for research-related purposes.

The enrolled subjects (n=70) will be divided into three sub-cohorts. Sub-Cohort 1 (n=60) will be monitored with EIT before, during, and after the administration of iNO (OFF-ON-OFF). Sub-Cohort 2 (n=10) will be monitored with EIT before and during the administration of iNO (OFF-ON) in the supine and in the prone position, and with DECT in the supine and in the prone position (without iNO). Sub-Cohort 3 (n=10) will be a subset of Cohort 1 and will be monitored with DECT before and during the administration of iNO, in addition to EIT monitoring before, during and after iNO administration (OFF-ON-OFF).

Methods to answer question 1 (To measure the topographic perfusion response to an iNO challenge with EIT):

- The EIT monitoring will be composed of ventilation and perfusion distributions. First, the ventilation is recorded; at this point, no additional maneuver is needed; the subjects need to wear the electrode belt connected to the device, and their ventilation will be recorded. Secondly, for the perfusion distribution, after a pause in the ventilation, EIT measures the distribution of blood perfusion in the lungs during the injection of a 10 mL bolus of 11.7% hypertonic saline solution through a central venous catheter. Cohort 1 (n=60) will receive 20ppm of iNO for 15 minutes. Cohort 1 will be monitored with EIT before, during, and after the iNO delivery in an OFF-ON-OFF fashion.

Methods to answer question 2 (To measure the topographic perfusion response to prone position, applied alone and in combination with iNO):

- Sub-Cohort 2 (n=10) will be monitored with EIT before and after 15 minutes receiving 20ppm iNO in an OFF-ON fashion, both in the supine and in the prone position. A second EIT measurement off iNO will not be obtained to minimize the total dose of hypertonic saline solution. The subjects will be transported to the computed tomography (CT) room, and DECT will be performed first in the supine position. A second DECT will be obtained after 30 minutes in the prone position. No iNO will be given during DECT.

Methods to answer question 3 (To compare changes of regional lung perfusion due to iNO detected by EIT against the changes detected by gold standard DECT):

- 10 subjects in Sub-Cohort 1 will receive DECT in addition to EIT monitoring in the supine position. DECT will be obtained before the iNO delivery. Then, the iNO delivery will start, and after 15 minutes, DECT will be repeated.

Methods to answer question 4 (to define correlations between EIT-derived perfusion changes during an iNO challenge and clinical characteristics and outcomes. ):

- The investigators will explore the vascular response measured by EIT from all 70 subjects and categorize subjects accordingly. The investigators plan to apply EIT patterns as an image marker and use them in conjunction with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS severity.

Finally,

• Blood MetHb levels will be continuously monitored before, during, and after each iNO administration of the day. At the end of each iNO administration, MetHb will continue to be monitored until values return to the level recorded before the current treatment and
• The NO, nitrogen dioxide (NO2) will be continuously monitored by INOmax DSIR (Mallinckrodt) deliver system.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maurizio F Cereda, MD; Phone Number: 6177263030; Email: mcereda@mgh.harvard.edu
• Study Contact Backup: Name: Roberta Ribeiro De Santis Santiago, MD, PhD; Phone Number: 6176437733; Email: rrsantiago@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Roberta Ribeiro De Santis Santiago; Phone Number: 6176437733; Email: rrsantiago@mgh.harvard.edu
      • Contact: Maurizio Cereda; Phone Number: 6177263030; Email: MCEREDA@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult intubated and mechanically ventilated patients (≥ 18 years old) admitted to the intensive care unit (ICU)
• ARDS diagnosis with mild to moderate severity by Berlin criteria1 (100 mmHg < PaO2/FiO2 <= 300 mmHg)
• Presence of an arterial line for blood gas measurement and blood pressure monitoring and of a central line for hypertonic saline injection

Exclusion Criteria:

• Suspected pregnancy, pregnancy or less than six weeks postpartum
• Younger than 18 years or older than 80 years
• Baseline methemoglobin ≥ 5%
• Subjects enrolled in another interventional research study
• Presence of pneumothorax
• Usage of any devices with electric current generation, such as a pacemaker or internal cardiac defibrillator
• Preexisting chronic lung disease or pulmonary hypertension
• Past medical history of lung malignancy or pneumonectomy, or lung transplant
• Left ventricle ejection fraction <20%

• Hemodynamic instability is defined as:

  • Persistent systolic blood pressure <90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators, or
  • Requiring an increment in inotropic vasopressors over the past two hours just before enrollment: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine, and more than 50 mcg/ min for phenylephrine.
• Hypernatremia (serum sodium > 150 mEq/L)

• Patients cannot be enrolled for DECT if they have:

  • History of allergic reaction to intravenous contrast
  • Renal dysfunction on the day of the study (serum creatinine > 1.5 mg/dL)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Impedance Tomography; A total of 60 subjects (Sub-Cohort 1) will receive an inhaled nitric oxide (iNO) challenge (20 ppm) for 15 min. The investigators will measure ventilation and perfusion distributions using EIT before iNO ("OFF1"), after 15 min on iNO ("ON"), and after 15 min washout ("OFF2") to confirm baseline stability.	Device: Nitric Oxide; 20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.; Other Names: inhaled nitric oxide (iNO)
Experimental: Electrical Impedance Tomography and Dual-Energy Computed Tomography in the Supine and Prone position; In a subset of 10 subjects (Sub-Cohort 2), EIT will be performed without and with iNO (OFF-ON) both in the supine and in the prone position. The OFF-ON fashion for EIT imaging is to minimize the subject's exposure to hypertonic saline solution. Sub-cohort 2 patient will be imaged also with DECT in the supine and after 30 minutes in the prone position. iNO will not be administered during DECT.	Device: Nitric Oxide; 20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.; Other Names: inhaled nitric oxide (iNO)
Experimental: Electrical Impedance Tomography with and without Inhaled Nitric Oxide in the Supine Position; 10 subjects (Sub-Cohort 3) from Sub-Cohort 1 will be monitored without iNO, with iNO, and without iNO (OFF-ON-OFF) in the supine position. Sub-Cohort 3 subjects will be imaged also with DECT. Imaging will be performed in the supine position without iNO and following iNO administration for 15 minutes (OFF-ON) .	Device: Nitric Oxide; 20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.; Other Names: inhaled nitric oxide (iNO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in regional lung perfusion after the delivery of inhaled nitric oxide	The primary outcome is to detect changes in regional perfusion distribution with the administration of inhaled nitric oxide with electrical impedance tomography by measuring changes in impedance.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare methods to detect change in regional lung perfusion after the delivery of inhaled nitric oxide	The secondary outcome is to To compare electrical impedance tomography measurements against the gold standard dual-energy computed tomography (DECT)	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes. Age (years)	Day 1
Gender	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Height	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Weight	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Race	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Ethnicity	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Comorbidities	Presence in the past medical history of conditions such as hypertension, diabetes,obesity, COPD, liver disease, and heart failure, among others. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Hours Elapsed since intubation	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1
Apache II score	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Within 24 hours of intensive care admission
Intensive care unit survival at 28 days	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 28
Hospital survival at 28 days	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 28
Ventilation-free days	This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
PaO2	The PaO2 will be measured with an arterial blood sample. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after iNO. Subsequent days up to 28 days will be determined by the critical care staff
PaCO2	The PaCO2 will be measured with an arterial blood sample. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after iNO. Subsequent days up to 28 days will be determined by the critical care staff
Ph	The Ph will be measured with an arterial blood sample. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after iNO. Subsequent days up to 28 days will be determined by the critical care staff
Methemoglobin (MetHb)	The MetHb will be measured with an arterial blood sample. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after iNO. Subsequent days up to 28 days will be determined by the critical care staff
HCO3 (bicarbonate)	The HCO3 will be measured with an arterial blood sample. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	Day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after iNO. Subsequent days up to 28 days will be determined by the critical care staff
Tidal Volume	Ventilator Parameter. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Plateau, peak and positive end-expiratory pressures	Ventilator Parameters are measured during tidal ventilation, inspiratory and expiratory holds. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Respiratory rate	Ventilator Parameters are measured during tidal ventilation, inspiratory and expiratory holds. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Flow	Ventilator Parameters are measured during tidal ventilation, inspiratory and expiratory holds. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Vasopressors requirements (dopamine, dobutamine, epinephrine, levosimendan, milrinone, vasopressin, norepinephrine)	We will calculate the Vasoactive-inotropic score (VIS). The VIS compares different vasoactive-inotropic drugs and doses among the patients. VIS = dopamine dose (mg/kg/min)+ dobutamine [mg/kg/min) +100 x epinephrine dose (mg/ kg/min) +50 x levosimendan dose [mg/kg/min) + 10 x milrinone dose [mg/kg/min)+ 10,000 x vasopressin [units/kg/min) + 100x norepinephrine dose [mg/kg/min) using the maximum dosing rates of vasoactive and inotropic medications. Ref: Koponen et al. British Journal of Anaesthesia, 122 (4): 428e436 (2019). This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Arterial blood pressure, central venous pressure, pulmonary artery pressure	Hemodynamic parameters. The pulmonary artery pressure will be measured if the subject have a pulmonary artery pressure placed by the ICU staff with clinical purposes. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
Life sustaining therapies	Other life-sustaining therapies than mechanical ventilation and vasopressors administration: Antibiotics, Renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO), chemotherapy, and artificial nutrition. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28
CRP, MCP-1, TNF-alpha, IL-6, IL-8, IL-10, Ang-2, VEGF	Blood samples will be collected and Systemic markers of inflammation and plasma cytokines: CRP, MCP-1, TNF-alpha, IL-6, IL-8, IL-10, Ang-2, VEGF will be measured. This exploratory outcome plans to utilize electrical impedance tomography as an image marker and combine them with other markers (demographical, radiological, clinical, biochemical, and inflammatory) to identify ARDS sub-phenotypes.	From day 1 to day 28

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Maurizio Cereda, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Johnson TR. Dual-energy CT: general principles. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S3-8. doi: 10.2214/AJR.12.9116.
• Safaee Fakhr B, Araujo Morais CC, De Santis Santiago RR, Di Fenza R, Gibson LE, Restrepo PA, Chang MG, Bittner EA, Pinciroli R, Fintelmann FJ, Kacmarek RM, Berra L. Bedside monitoring of lung perfusion by electrical impedance tomography in the time of COVID-19. Br J Anaesth. 2020 Nov;125(5):e434-e436. doi: 10.1016/j.bja.2020.08.001. Epub 2020 Aug 7. No abstract available.
• Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
• Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29.
• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
• Cressoni M, Caironi P, Polli F, Carlesso E, Chiumello D, Cadringher P, Quintel M, Ranieri VM, Bugedo G, Gattinoni L. Anatomical and functional intrapulmonary shunt in acute respiratory distress syndrome. Crit Care Med. 2008 Mar;36(3):669-75. doi: 10.1097/01.CCM.0000300276.12074.E1.
• Zapol WM, Kobayashi K, Snider MT, Greene R, Laver MB. Vascular obstruction causes pulmonary hypertension in severe acute respiratory failure. Chest. 1977 Feb;71(2 suppl):306-7. doi: 10.1378/chest.71.2_supplement.306. No abstract available.
• Greene R, Zapol WM, Snider MT, Reid L, Snow R, O'Connell RS, Novelline RA. Early bedside detection of pulmonary vascular occlusion during acute respiratory failure. Am Rev Respir Dis. 1981 Nov;124(5):593-601. doi: 10.1164/arrd.1981.124.5.593. No abstract available.
• Tomashefski JF Jr, Davies P, Boggis C, Greene R, Zapol WM, Reid LM. The pulmonary vascular lesions of the adult respiratory distress syndrome. Am J Pathol. 1983 Jul;112(1):112-26.
• Rossaint R, Falke KJ, Lopez F, Slama K, Pison U, Zapol WM. Inhaled nitric oxide for the adult respiratory distress syndrome. N Engl J Med. 1993 Feb 11;328(6):399-405. doi: 10.1056/NEJM199302113280605.
• Morais CCA, Safaee Fakhr B, De Santis Santiago RR, Di Fenza R, Marutani E, Gianni S, Pinciroli R, Kacmarek RM, Berra L. Bedside Electrical Impedance Tomography Unveils Respiratory "Chimera" in COVID-19. Am J Respir Crit Care Med. 2021 Jan 1;203(1):120-121. doi: 10.1164/rccm.202005-1801IM. No abstract available.
• De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Acute respiratory distress syndrome; Electrical impedance tomography; Ventilation/perfusion mismatch; Inhaled nitric oxide; Dual-energy computed tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome; Respiratory Aspiration; Diagnostic Techniques and Procedures; Diagnosis; Breath Tests; Fractional Exhaled Nitric Oxide Testing
• Other Study ID Numbers: 2023p000138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes