Collapsed LungNCT06097026
Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function
A study testing Alveolar recruitment maneuver and Nitric Oxide in people with Collapsed Lung and Hemodynamic Stability, run by Fernando Suarez Sipmann at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the role of nitric oxide on pulmonary vasculature and right ventricular function in postoperative cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Collapsed Lung, Hemodynamic Stability
- What is being tested?
- Alveolar recruitment maneuver and Nitric Oxide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age > 18 years
- Under controlled mechanical ventilation in passive conditions
- Presence of postoperative lung collapse (confirmed by pulmonary echocardiography and Air test)
- Preoperative left ventricular ejection fraction (LVEF) ≥ 30%.
- Absence of hypovolemia: absence of "kissing" ventricles and/or collapsibility index of the superior vena cava < 20%.
- Stable spontaneous heart rhythm
- Postoperative hemodynamic stability:
- Mean arterial pressure (MAP) ≥ 60 mmHg
- Central venous pressure (CVP) ≥ 10 mmHg
- Heart rate (HR) ≤ 100 bpm without tachyarrhythmias
- Lactic acid ≤ 3 mmol/L
- Single vasopressor treatment
- Norepinephrine dose ≤ 0.2 μg/kg/min, without an increase ≥ 15% in the last 30 -minutes.
Obtained informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fernando Suárez Sipmann
Madrid, 28006
Fernando Suarez Sipman, 915 20 22 00, fsuarezsipmann@gmail.com
Isabel Magana Bru, 915 20 22 00, isabelmgbru@gmail.com
About this study
Official title: Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function Following Cardiac Surgery
The aim of this study is to evaluate the role of nitric oxide on pulmonary vasculature and right ventricular function in postoperative cardiac surgery patients.
Read the detailed description
This study will evaluate modifiable pathophysiological treatments for postoperative pulmonary hypertension and right ventricular dysfunction.
One pharmacological, inhaled nitric oxide, and one non-pharmacological, the OLA strategy combining lung recruitment and stabilization with individually optimized positive end-expiratory pressure (PEEP) and the possible synergistic effects of both interventions on right ventricular performance. Apart from acting specifically on the pathophysiological mechanisms described, the combination of an OLA strategy and iNO may be particularly beneficial, as modification of pulmonary status by OLA may, in theory, enhance the effects of iNO by significantly increasing gas exchange area and thus alveolar ventilation.
A number of closely related physiological variables will also be studied to better characterize the effects of both strategies and their combination. This may help to better establish the indication for iNO in cardiac surgery patients and improve our understanding of mechanisms that are also present in ARDS patients, albeit on a different scale.
This is a prospective randomized controlled physiological prospective study to be performed in two hospitals. The intervention period is limited to the first 2 -3 hours postoperatively. A total of 54 patients will be recruited.
- Conditions
- Collapsed Lung, Hemodynamic Stability
- Being tested
- Alveolar recruitment maneuver, Nitric Oxide
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitment maneuverProcedure or surgery
Also called Alveolar recruitment
Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.
Nitric OxideDrug
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment (CONT) | No intervention | The patient will be managed according to the routine clinical protocol, homogenizing the interventions in both participating centers. |
| iNO 20-40 ppm | Experimental | In this arm, inhaled nitric oxide therapy will be initiated at 20 ppm immediately after randomization and after initial data collection. The dose will be reassessed after the first 30 min and may be increased to a maximum of 40 ppm depending on the response observed in ventricular function. Receives: Drug: Nitric Oxide |
| iNO 20 - 40 ppm + Lung recruitment (iNO-RM) | Experimental | After 30 min after initiation of nitric oxide therapy following randomization, once patient stability has been confirmed, a brief recruitment maneuver will be performed and the subsequent PEEP level will be individualized according to the best lung compliance. Ventilation will then continue with the standard baseline ventilator settings, but with the PEEP level individually optimized. Receives: Procedure: Alveolar recruitment maneuver; Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling
The parameters will be evaluated by TEE. Right ventricular function parameters will be assessed by the ratio of right ventricular end-diastolic to left ventricular end-diastolic diameters, right ventricular shortening fraction, tricuspid annular plane systolic excursion (TAPSE), myocardial performance index (MPI). estimation of systolic pulmonary artery pressure (PAPs), estimation of pulmonary vascular resistance by Doppler, Right ventricular outflow tract notch pattern, right ventricular outflow tract acceleration time (RVOT-AT).
Measured: A first TTE baseline measurement (T1) will be taken after arrival in the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (at iNO) (T2), and a new measurement will be taken 30 minutes later (T3).
Secondary outcomes (1)
Electrical impedance tomography (EIT) derived variables
With electrical impedance tomography (EIT), investigators will analyze the regional distribution of lung ventilation and percussion, the relative distribution of ventilation and percussion in predefined regions of interest, changes in lung aeration (end-expiratory lung volume difference) and pulmonary artery pulsatility.
Measured: A first baseline measurement (T1) will be taken after arrival at the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (in iNO) (T2), and a new measurement will be taken 30 minutes later (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start22 Nov 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collapsed LungStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Suarez Sipmann
- Sponsor type
- University, hospital or other
- Collaborators
- Air Liquide SA
- Responsible party
- Sponsor-investigator, Fernando Suarez Sipmann, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097026
- Sponsor's protocol ID
- RONNIN- CCV
- Status last verified
- Feb 2024
- First submitted
- 26 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06097026
- Acronym / sponsor ID
- RONNIN- CCV
- Conditions
- Collapsed Lung, Hemodynamic Stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fernando Suarez SipmannUniversity, hospital or other
- Collaborators
- Air Liquide SA
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
The aim of this study is to evaluate the role of nitric oxide on pulmonary vasculature and right ventricular function in postoperative cardiac surgery patients.
Detailed description
This study will evaluate modifiable pathophysiological treatments for postoperative pulmonary hypertension and right ventricular dysfunction.
One pharmacological, inhaled nitric oxide, and one non-pharmacological, the OLA strategy combining lung recruitment and stabilization with individually optimized positive end-expiratory pressure (PEEP) and the possible synergistic effects of both interventions on right ventricular performance. Apart from acting specifically on the pathophysiological mechanisms described, the combination of an OLA strategy and iNO may be particularly beneficial, as modification of pulmonary status by OLA may, in theory, enhance the effects of iNO by significantly increasing gas exchange area and thus alveolar ventilation.
A number of closely related physiological variables will also be studied to better characterize the effects of both strategies and their combination. This may help to better establish the indication for iNO in cardiac surgery patients and improve our understanding of mechanisms that are also present in ARDS patients, albeit on a different scale.
This is a prospective randomized controlled physiological prospective study to be performed in two hospitals. The intervention period is limited to the first 2 -3 hours postoperatively. A total of 54 patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment (CONT) | No intervention | –The patient will be managed according to the routine clinical protocol, homogenizing the interventions in both participating centers. |
| iNO 20-40 ppm | Experimental | Drug: Nitric OxideIn this arm, inhaled nitric oxide therapy will be initiated at 20 ppm immediately after randomization and after initial data collection. The dose will be reassessed after the first 30 min and may be increased to a maximum of 40 ppm depending on the response observed in ventricular function. |
| iNO 20 - 40 ppm + Lung recruitment (iNO-RM) | Experimental | Procedure: Alveolar recruitment maneuver, Drug: Nitric OxideAfter 30 min after initiation of nitric oxide therapy following randomization, once patient stability has been confirmed, a brief recruitment maneuver will be performed and the subsequent PEEP level will be individualized according to the best lung compliance. Ventilation will then continue with the standard baseline ventilator settings, but with the PEEP level individually optimized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Alveolar recruitment maneuverAlso: Alveolar recruitmentProgressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation. | Procedure or surgery | iNO 20 - 40 ppm + Lung recruitment (iNO-RM) |
| Nitric OxideAdminister nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards. | Drug | iNO 20 - 40 ppm + Lung recruitment (iNO-RM), iNO 20-40 ppm |
Primary outcome
Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling
Time frame: A first TTE baseline measurement (T1) will be taken after arrival in the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (at iNO) (T2), and a new measurement will be taken 30 minutes later (T3).
The parameters will be evaluated by TEE. Right ventricular function parameters will be assessed by the ratio of right ventricular end-diastolic to left ventricular end-diastolic diameters, right ventricular shortening fraction, tricuspid annular plane systolic excursion (TAPSE), myocardial performance index (MPI). estimation of systolic pulmonary artery pressure (PAPs), estimation of pulmonary vascular resistance by Doppler, Right ventricular outflow tract notch pattern, right ventricular outflow tract acceleration time (RVOT-AT).
1 secondary outcome
Electrical impedance tomography (EIT) derived variables
Time frame: A first baseline measurement (T1) will be taken after arrival at the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (in iNO) (T2), and a new measurement will be taken 30 minutes later (T3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar recruitment maneuver and Nitric Oxide in people with Collapsed Lung and Hemodynamic Stability, run by Fernando Suarez Sipmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Suarez Sipmann, MD PhD (+34 915202200, fsuarezsipmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling (time frame: A first TTE baseline measurement (T1) will be taken after arrival in the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (at iNO) (T2), and a new measurement will be taken 30 minutes later (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.