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NCT06026670: PEEP-RATS
Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery
trial in Ventilator-Induced Lung Injury in 30 participants. Completed in 26 February 2024.
20 February 2024
Quick facts
| Lead sponsor | Hospital Clinic of Barcelona |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 3 July 2023 |
| Primary completion | 20 February 2024 |
| Estimated completion | 26 February 2024 |
| Sites | 1 location across Spain |
Conditions studied
- Ventilator-Induced Lung Injury — all drugs for Ventilator-Induced Lung Injury →
Sponsor
Hospital Clinic of Barcelona
Who can join
Adults 18 to 120, any sex, with Ventilator-Induced Lung Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications. During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC). In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP). However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection. Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
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 NCT06026670
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ventilator-Induced Lung Injury
Currently open trials in the same condition.
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- NCT06526598 — Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial · NA · recruiting
- NCT06296173 — Open Lung Protective Extubation Following General Anesthesia · NA · recruiting
- NCT06572280 — Non-invasive Phrenic Nerve Stimulation in ARDS Patient · NA · recruiting
- NCT05875883 — Phrenic Identification in the ICU · active not recruiting
Other Hospital Clinic of Barcelona trials
Trials by the same sponsor.
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- NCT07358611 — Non-invasive Mapping-Guided Atrial Fibrillation Ablation · NA · recruiting
- NCT07237867 — Frequency-Dependent Effects of Percutaneous Femoral Nerve Stimulation on Quadriceps Strength in Athletes With Patellar T · NA · recruiting
- NCT07163936 — Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Diseas · 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 NCT06026670 (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 Hospital Clinic of Barcelona
- Last refreshed: 28 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/NCT06026670.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing