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NCT02596178
Titration of PEEP During Mechanical Ventilation in Patients With ARDS Using Electrical Impedance Tomography.
NA trial testing Electrical Impedance Tomography in Acute Respiratory Distress Syndrome. Withdrawn.
1 December 2019
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 March 2016 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 July 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Electrical Impedance Tomography
Conditions studied
- Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
Sponsor
Boston Children's Hospital
Who can join
Adults 2 to 35, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lung units that participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units that do not participate in gas exchange (i.e. the derecruited lung), which results in impaired gas exchange and induces an inflammatory cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement, the other using a higher PEEP level. The primary purpose of this study is to demonstrate the safety and efficacy of an electrical impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit) and Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in lung volume as assessed by electrical impedance tomography, lung compliance and by an improvement in markers of gas exchange. Safety will be defined as the incidence of barotrauma and hemodynamic consequences that occur during the protocol. Those results will be compared to incidences of barotrauma and hemodynamic compromise within the ARDS literature. Knowledge gained from this pilot will be instrumental in developing an EIT imagine guided protocol which will allow us to conduct future RCTs utilizing EIT technology
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02596178
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Related trials
Other trials of Electrical Impedance Tomography
Trials testing the same drug.
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- NCT06827184 — By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for · recruiting
- NCT05823688 — Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy · recruiting
- NCT06642701 — Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia · NA · completed
- NCT04757025 — Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy. · NA · unknown
Other recruiting trials for Acute Respiratory Distress Syndrome
Currently open trials in the same condition.
- NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting
- NCT07289711 — Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter C · recruiting
- NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
- NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
- NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting
Other Boston Children's Hospital trials
Trials by the same sponsor.
- NCT06804382 — Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP · NA · not yet recruiting
- NCT05113394 — Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy · Phase 2 · withdrawn
- NCT06434220 — Effect of Predictive Model on ED Physician Assessments of Patient Disposition · NA · not yet recruiting
- NCT07476430 — Readiness Outcomes Affecting Return to Sport 3.0 · NA · not yet recruiting
- NCT06706336 — Radon Asthma Intervention Trial · NA · not yet recruiting
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 NCT02596178 (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 Boston Children's Hospital
- Last refreshed: 5 June 2019
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