Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304779
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection IAIThe secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation protection of important organ function during the perioperative period length of hospital stay and outcomes within 30 days postoperatively
Detailed Description:
PPCs are defined as the occurrence within 2 days postoperatively of atelectasis unplanned ventilation acute respiratory distress syndrome ARDS and postoperative pneumonia syndrome Unplanned ventilation postoperatively Defined as the use of non-invasive mechanical ventilation invasive mechanical ventilation or extracorporeal membrane oxygenation ECMO after the first extubation postoperatively or if extubation cannot be performed as planned
Acute Respiratory Distress Syndrome ARDS Defined as acute diffuse inflammatory lung injury leading to increased pulmonary vascular permeability increased lung weight loss of aerated lung tissue hypoxemia and bilateral opacities on imaging using the Berlin Consensus definition
Postoperative pneumonia Defined according to the diagnostic criteria in the Chinese Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Diagnosis and Treatment Guidelines 2018 version new or progressive infiltrates consolidation or ground-glass opacities on chest X-ray or CT along with two or more of the following clinical symptoms ① fever 380C ② purulent respiratory secretions ③ peripheral blood leukocyte count 10109L or 4109L
Acute Respiratory Distress Syndrome ARDS Defined as acute diffuse inflammatory lung injury leading to increased pulmonary vascular permeability increased lung weight loss of aerated lung tissue hypoxemia and bilateral opacities on imaging using the Berlin Consensus definition
Postoperative pneumonia Defined according to the diagnostic criteria in the Chinese Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Diagnosis and Treatment Guidelines 2018 version new or progressive infiltrates consolidation or ground-glass opacities on chest X-ray or CT along with two or more of the following clinical symptoms ① fever 380C ② purulent respiratory secretions ③ peripheral blood leukocyte count 10109L or 4109L
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