Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282003
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-30
Brief Title:
Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications
Sponsor:
Masa Kontic
Organization:
Croatian Health Insurance Fund
Study Overview
Official Title:
Protective Lung Ventilation Procedure During General Anesthesia Reduces the Incidence of Pulmonary Complications After Abdominal Surgery Possibly
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Anesthetic effects surgery and invasive mechanical intubation can impair respiratory function during general anesthesia The risk factors for postoperative pulmonary complications PPCs include the type of surgery and duration ventilation-perfusion discrepancy and the presence of pain Mitigating PPCs under anesthesia is a goal but effective strategies are yet to be defined Conventional ventilation CV procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance The protective lung ventilation PV procedure on the other hand includes high positive end-expiratory pressure lung recruitment maneuver oxygen saturation levels above 94 lower inspired oxygen levels and continuous positive airway pressure before the tube is removed In this study 56 consecutive patients undergoing abdominal surgery were randomly assigned with 30 in the CV and 23 in the PV group while 3 were lost during the follow-up We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs recommending these strategies be adopted as the standard practice in general anesthesia
Detailed Description:
Additionally despite accumulated knowledge and careful monitoring sometimes an anesthesiologist is still unable to entirely avoid the occurrence of atelectasis a common phenomenon observed during general anesthesia Altogether it can be concluded that the effects of mechanical ventilation and oxygenation over an extended period are not yet well understood particularly regarding the impact of reducing tidal volume and using higher PEEPs This study was a prospective single-center randomized controlled patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective optimized ventilation procedure PV group of patients compared to the conventional standard method of lung ventilation CV during general anesthesia
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