Last reviewed · How we verify

NCT06026670: PEEP-RATS

Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery

Completed Last updated 28 February 2024
What this trial tests

trial in Ventilator-Induced Lung Injury in 30 participants. Completed in 26 February 2024.

Timeline
3 July 2023
Primary endpoint
20 February 2024
26 February 2024

Quick facts

Lead sponsorHospital Clinic of Barcelona
StatusCompleted
Study typeOBSERVATIONAL
Enrollment30
Start date3 July 2023
Primary completion20 February 2024
Estimated completion26 February 2024
Sites1 location across Spain

Conditions studied

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:

Other recruiting trials for Ventilator-Induced Lung Injury

Currently open trials in the same condition.

Other Hospital Clinic of Barcelona trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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