Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03364465
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2017-11-22
Brief Title:
Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume
Sponsor:
University of Debrecen
Organization:
University of Debrecen
Study Overview
Official Title:
Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-04
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 low tidal volume 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 tidal volume with recruitment maneuvers during thoracic surgery in adults
We hypothesize that in adult non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs
Patients will be randomly assigned to one of two groups
FIX TIDAL VOLUME GROUP Groupfix mechanical ventilation with constant 6 mlkgIBW tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE TIDAL VOLUME GROUP Groupvar mechanical ventilation with variable 6 mlkgIBW 33 tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers
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 low tidal volume 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 tidal volume with recruitment maneuvers during thoracic surgery in adults
We hypothesize that in adult non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs
Patients will be randomly assigned to one of two groups
FIX TIDAL VOLUME GROUP Groupfix mechanical ventilation with constant 6 mlkgIBW tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE TIDAL VOLUME GROUP Groupvar mechanical ventilation with variable 6 mlkgIBW 33 tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O 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 will be 6 mlkg predicted body weight 33 with 5 cmH2O PEEP Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation
In GroupVar VT will be 6 mlkg predicted body weight 33 with 5 cmH2O PEEP Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation
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