Viewing Study NCT03968120



Ignite Creation Date: 2024-05-06 @ 1:13 PM
Last Modification Date: 2024-10-26 @ 1:11 PM
Study NCT ID: NCT03968120
Status: COMPLETED
Last Update Posted: 2024-01-05
First Post: 2019-05-14

Brief Title: Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome
Sponsor: University of Debrecen
Organization: University of Debrecen

Study Overview

Official Title: 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
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 mlkgIBW tidal volume and PEEP of 5 cmH2O with recruitment maneuvers

VARIABLE PEEP GROUP Groupvar mechanical ventilation with constant 6 mlkgIBW 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 mLkg predicted body weight During one-lung ventilation in GroupFix VT will be decreased to 6 mLkg PBW with 5 cmH2O PEEP

In GroupVar VT mechanical ventilation with constant 6 mlkgIBW tidal volume with variable PEEP with recruitment maneuvers

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None