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NCT03083457: PEEP-RM
Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
NA trial testing Fluid resuscitation or amine administration in Anesthesia, General in 30 participants. Completed in 30 November 2020.
30 November 2020
Quick facts
| Lead sponsor | Catholic University of the Sacred Heart |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 March 2017 |
| Primary completion | 30 November 2020 |
| Estimated completion | 30 November 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Fluid resuscitation or amine administration — full drug profile →
- General anesthetic — full drug profile →
- Fluid administration — full drug profile →
- Low-tidal volume ventilation
- Scheduled recruiting maneuvers
Conditions studied
- Anesthesia, General — all drugs for Anesthesia, General →
- Surgery — all drugs for Surgery →
Sponsor
Catholic University of the Sacred Heart
Who can join
18 and older, any sex, with Anesthesia, General or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery. A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established. Design: prospective, cross-over, physiological trial. PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03083457
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Catholic University of the Sacred Heart trials
Trials by the same sponsor.
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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 NCT03083457 (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 Catholic University of the Sacred Heart
- Last refreshed: 29 January 2021
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/NCT03083457.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing