ARDS, HumanNCT04141293
Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation
A study testing alveolar recruitment in people with ARDS, Human, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
Trial summary
According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- alveolar recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHungary
- Study dates
- 1 Aug 2017to 1 Nov 2021
- 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
Who may be able to join
- orotracheal intubation
- pressure supported ventilation
- moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O
Who cannot join
- age < 18 years
- pregnancy
- previous pulmonary resection, pulmonectomy
- clinically verified, end-stage COPD
- severe hemodynamic instability (i.e. refractory shock to vasopressors)
- severe emphysema and/or spontaneous pneumothorax in past medical history
- contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Szeged, Department of Anesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725
About this study
Official title: Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation
According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.
Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.
The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.
- Conditions
- ARDS, Human
- Being tested
- alveolar recruitment
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitmentProcedure or surgery
Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Experimental | Not described Receives: Procedure: alveolar recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment
Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations
Measured: Approximately 35 minutes
Secondary outcomes (7)
Changes in left and right ventricular volume (systolic ventricular interdependence)
Left ventricular end-systolic eccentricity index will be assessed by transthoracal echocardiogarphy and will be compared with transpulmonary pressure alterations.
Measured: Approximately 3 minutes
Changes in pulmonary air content
Changes in pulmonary atelectasis will be assessed by electrical impedance tomography (EIT) - mean impedance variation in % and will be compared with arterial oxygen content.
Measured: Approximately 30 miniutes
Changes in arterial oxygen content
Pre- and post-recruitment arterial oxygenation (PaO2 mmHg) will be measured by blood gas machine and will be compared to EIT measurements.
Measured: Approximately 5 minutes
Changes in hemodynamic parameters (SV)
Changes in stroke volume (ml)
Measured: 35 minutes
Changes in hemodynamic parameters (MAP)
Changes in mean arterial pressure (mmHg)
Measured: 35 minutes
Changes in hemodynamic parameters (HR)
Changes in heart rate (1/min)
Measured: 35 minutes
Changes in hemodynamic parameters (CI)
Changes in cardiac index (l/min/2m)
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Aug 2017
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Why it stopped: Technical problems and employee shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Sponsor type
- Other government
- Responsible party
- Principal investigator, András Lovas, Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141293
- Sponsor's protocol ID
- 101/2017-SZTE
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2017
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
PubMed 26682219Lovas A, Nemeth MF, Trasy D, Molnar Z. Lung recruitment can improve oxygenation in patients ventilated in continuous positive airway pressure/pressure support mode. Front Med (Lausanne). 2015 Apr 21;2:25. doi: 10.3389/fmed.2015.00025. eCollection 2015.
PubMed 25954744Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
PubMed 24597883ARDS 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.
PubMed 22797452
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04141293
- Acronym / sponsor ID
- 101/2017-SZTE
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems and employee shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of SzegedOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 28 Oct 2019 (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.
According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.
Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.
The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | Experimental | Procedure: alveolar recruitment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- orotracheal intubation
- pressure supported ventilation
- moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O
Key exclusion criteria (7 listed)
- age < 18 years
- pregnancy
- previous pulmonary resection, pulmonectomy
- clinically verified, end-stage COPD
- severe hemodynamic instability (i.e. refractory shock to vasopressors)
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 recruitmentAlveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure. | Procedure or surgery | Eligible patients |
Primary outcome
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment
Time frame: Approximately 35 minutes
Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations
7 secondary outcomes
Changes in left and right ventricular volume (systolic ventricular interdependence)
Time frame: Approximately 3 minutes
Changes in pulmonary air content
Time frame: Approximately 30 miniutes
Changes in arterial oxygen content
Time frame: Approximately 5 minutes
Changes in hemodynamic parameters (SV)
Time frame: 35 minutes
Changes in hemodynamic parameters (MAP)
Time frame: 35 minutes
Changes in hemodynamic parameters (HR)
Time frame: 35 minutes
Changes in hemodynamic parameters (CI)
Time frame: 35 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 26682219Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
- Background: PubMed 25954744Lovas A, Nemeth MF, Trasy D, Molnar Z. Lung recruitment can improve oxygenation in patients ventilated in continuous positive airway pressure/pressure support mode. Front Med (Lausanne). 2015 Apr 21;2:25. doi: 10.3389/fmed.2015.00025. eCollection 2015.
- Background: PubMed 24597883Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
- Background: PubMed 22797452ARDS 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with ARDS, Human, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 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 Hungary. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment (time frame: Approximately 35 minutes). 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 NCT04141293, which also lists 4 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 20 Feb 2024.