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NCT04141293
Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation
NA trial testing alveolar recruitment in ARDS, Human. Withdrawn.
1 November 2021
Quick facts
| Lead sponsor | Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Start date | 1 August 2017 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 1 location across Hungary |
Drugs / interventions tested
- alveolar recruitment
Conditions studied
- ARDS, Human — all drugs for ARDS, Human →
Sponsor
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Who can join
18 and older, any sex, with ARDS, Human. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04141293
- Europe PMC full search
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Related trials
Other trials of alveolar recruitment
Trials testing the same drug.
- NCT04360837 — PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill Corona Virus Disease-19 (COVID-19) Patients · NA · completed
Other recruiting trials for ARDS, Human
Currently open trials in the same condition.
- NCT07070362 — Digital Early Warning System for Acute Lung Injury in Liver Surgery · recruiting
- NCT06572280 — Non-invasive Phrenic Nerve Stimulation in ARDS Patient · NA · recruiting
- NCT06119516 — Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study. · NA · recruiting
- NCT06321497 — Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury · recruiting
- NCT06486259 — Regional Assessment of the Risk of Lung Injury in Ventilated Patients · recruiting
Other Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged trials
Trials by the same sponsor.
- NCT06359119 — Implementation of Apnoea Test for Patients With Suspected Brain Death · not yet recruiting
- NCT06290310 — Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography · unknown
- NCT04857242 — Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death · NA · completed
- NCT04174014 — Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04141293 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04141293.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing