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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635281
• Other study ID #: OLVRM
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: January 2019
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing VATS with OLV =2 hours

Exclusion Criteria:

• ASA (American Society of Anesthesiologists Physical Status Classi?cation) 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),

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Procedure:
• Recruitment manoeuvers
Recruitment manoeuvers will be performed as follow Recruitment manoeuvers set FIO2 at 1.0 Ppeak limit at 45 cmH2O Respiratory rate set at 6 I:E set at 1:1 Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O If the maximum VT is set without rasing the Pplat, raise PEEP Allow three respiratory cycles with Pplat between 30 and 40 cmH2O 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).
• incremental PEEP
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

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Spadaro S, Grasso S, Karbing DS, Fogagnolo A, Contoli M, Bollini G, Ragazzi R, Cinnella G, Verri M, Cavallesco NG, Rees SE, Volta CA. Physiologic Evaluation of Ventilation Perfusion Mismatch and Respiratory Mechanics at Different Positive End-expiratory P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative oxygenation, measured as PaO2/FIO2 ratio		20 minutes after intervention
Primary	pulmonary shunt, expressed as percentage, measured by ALPE system		20 minutes after intervention
Secondary	intraoperative driving pressure, measured as plateau pressure - PEEP		20 minutes after intervention