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NCT05737407
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia
NA trial testing LUS-guided choice of Peep in Oxygen Toxicity in 280 participants. Currently enrolling.
30 June 2024
Quick facts
| Lead sponsor | Vittore Buzzi Children's Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 280 |
| Start date | 1 March 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 15 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- LUS-guided choice of Peep
- Standard choice of Peep
Conditions studied
- Oxygen Toxicity — all drugs for Oxygen Toxicity →
- Anesthesia; Adverse Effect — all drugs for Anesthesia; Adverse Effect →
Sponsor
Vittore Buzzi Children's Hospital
Who can join
Adults 33 Weeks to 50 Weeks, any sex, with Oxygen Toxicity or Anesthesia; Adverse Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this RCT is to demonstrate that, in neonatal anesthesia, the use of Lung Ultrasound (LUS) to guide choice of best Positive End-Expiratory Pressure (Peep) - the one that efficiently avoids lung atelectasis - leads to better gas exchange in the lung thus can lead to reduction of FiO2 applied to ventilatory setting in order to achieve same peripheral saturations of oxygen (SpO2). Specific aims of the study are: 1. to determine if LUS-guided PEEP choice in neonatal anesthesia, compared to standard PEEP choice, can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s. 2. to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours. 3. to compare static respiratory system compliance between groups. 4. to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05737407
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other recruiting trials for Oxygen Toxicity
Currently open trials in the same condition.
- NCT05761756 — Oxygen Toxicity: Mechanisms in Humans · NA · recruiting
Other Vittore Buzzi Children's Hospital trials
Trials by the same sponsor.
- NCT05737394 — Lap-guided vs Us-guided TAP Block in Pediatric Laparoscopy · NA · recruiting
- NCT07042854 — Volume-Controlled vs Pressure-Regulated Volume Control Ventilation in Pediatric Anesthesia: an Electrical Impedance Tomo · completed
- NCT06425107 — Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection · recruiting
- NCT05823688 — Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy · recruiting
- NCT06069414 — Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia · completed
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 NCT05737407 (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 Vittore Buzzi Children's Hospital
- Last refreshed: 10 May 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/NCT05737407.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing