Clinical Trials Directory

Trials / Completed

CompletedNCT03968120

Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome

Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
University of Debrecen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults. The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.

Detailed description

Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP. In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.

Conditions

Interventions

TypeNameDescription
OTHERChange of ventilatory settingsChange of Positive End-Exspiratory Pressure during one-lung ventilation

Timeline

Start date
2018-02-01
Primary completion
2019-09-30
Completion
2019-09-30
First posted
2019-05-30
Last updated
2024-01-05

Locations

1 site across 1 country: Hungary

Source: ClinicalTrials.gov record NCT03968120. Inclusion in this directory is not an endorsement.