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Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation

Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone on Ventilation Perfusion Mismatch and Respiratory Mechanics in One Lung Ventilation. A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03635281
Enrollment
60
Registered
2018-08-17
Start date
2017-08-01
Completion date
2018-10-30
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Brief summary

The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the optimal PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery

Interventions

PROCEDURERecruitment manoeuvers

Recruitment manoeuvers will be performed as follow Recruitment manoeuvers 1. set FIO2 at 1.0 2. Ppeak limit at 45 cmH2O 3. Respiratory rate set at 6 4. I:E set at 1:1 5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O 6. If the maximum VT is set without rasing the Pplat, raise PEEP 7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O 8. End of RM The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).

In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

• Patients undergoing VATS with OLV ≥2 hours

Exclusion criteria

* ASA (American Society of Anesthesiologists Physical Status Classification) score ≥ 4 * severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4 * preoperative hemoglobin less than 10 g ml-1 * hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),

Design outcomes

Primary

MeasureTime frame
pulmonary shunt, expressed as percentage, measured by ALPE system20 minutes after intervention

Secondary

MeasureTime frame
intraoperative driving pressure, measured as plateau pressure - PEEP20 minutes after intervention

Other

MeasureTime frame
intraoperative oxygenation, measured as PaO2/FIO2 ratio20 minutes after intervention

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026