Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248320
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-30
Brief Title:
Sigh Ventilation on Postoperative Hypoxemia in Cardiac Surgery
Sponsor:
Zhongda Hospital
Organization:
Zhongda Hospital
Study Overview
Official Title:
Effect of Perioperative Sigh Ventilation on Postoperative Hypoxemia and Pulmonary Complications After On-pump Cardiac Surgery A Randomized Controlled Trial
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:
Postoperative pulmonary complications PPCs remain a frequent event after pump-on cardiac surgery and are mostly characterized by postoperative hypoxemiaThese complications are significant contributors to prolonged intensive care unit admissions and an escalation in in-hospital mortality rates
The dual impact of general anesthesia with invasive mechanical ventilation results in ventilator-induced lung injury while cardiac surgery introduces additional pulmonary insults These include systemic inflammatory responses initiated by cardiopulmonary bypass and ischemic lung damage consequent to aortic cross-clamping Contributing factors such as blood transfusions and postoperative pain further exacerbate the incidence of PPCs by increasing the permeability of the alveolo-capillary barrier and disrupting mucociliary functions often culminating in pulmonary atelectasis
Protective ventilation strategies inspired by acute respiratory distress syndrome ARDS management protocols involve the utilization of low tidal volumes 6-8mLkg predicted body weight However the uniform application of low tidal volumes especially when combined with the multifactorial pulmonary insults inherent to cardiac surgery can precipitate surfactant dysfunction and induce atelectasis
The role of pulmonary surfactant in maintaining alveolar stability is critical necessitating continuous synthesis to sustain low surface tension and prevent alveolar collapse The most potent stimulus for surfactant secretion is identified as the mechanical stretch of type II pneumocytes typically induced by larger tidal volumes
This background sets the foundation for a research study aimed at assessing the safety and efficacy of incorporating sighs into perioperative protective ventilation This approach is hypothesized to mitigate postoperative hypoxemia and reduce the incidence of PPCs in patients undergoing scheduled on-pump cardiac surgery
The dual impact of general anesthesia with invasive mechanical ventilation results in ventilator-induced lung injury while cardiac surgery introduces additional pulmonary insults These include systemic inflammatory responses initiated by cardiopulmonary bypass and ischemic lung damage consequent to aortic cross-clamping Contributing factors such as blood transfusions and postoperative pain further exacerbate the incidence of PPCs by increasing the permeability of the alveolo-capillary barrier and disrupting mucociliary functions often culminating in pulmonary atelectasis
Protective ventilation strategies inspired by acute respiratory distress syndrome ARDS management protocols involve the utilization of low tidal volumes 6-8mLkg predicted body weight However the uniform application of low tidal volumes especially when combined with the multifactorial pulmonary insults inherent to cardiac surgery can precipitate surfactant dysfunction and induce atelectasis
The role of pulmonary surfactant in maintaining alveolar stability is critical necessitating continuous synthesis to sustain low surface tension and prevent alveolar collapse The most potent stimulus for surfactant secretion is identified as the mechanical stretch of type II pneumocytes typically induced by larger tidal volumes
This background sets the foundation for a research study aimed at assessing the safety and efficacy of incorporating sighs into perioperative protective ventilation This approach is hypothesized to mitigate postoperative hypoxemia and reduce the incidence of PPCs in patients undergoing scheduled on-pump cardiac surgery
Detailed Description:
The purpose of this single center parallel group randomized controlled study is to evaluate the effect of a perioperative sigh ventilation strategy on postoperative outcomes during the first 7 days following cardiac surgery The study will include 192 adult patients undergoing scheduled on-pump cardiac surgery The sigh ventilation approach will combine sigh ventilation and lung protective ventilation 6-8 mlkgpbw from intubation to extubation It will be compared to a conventional approach without sigh ventilation with lung protective ventilation and positive end-expiratory pressure PEEP setting same as the intervention arm The primary endpoint is the Spo2Fio2 ratio during the initial post extubation hour The secondary endpoints are postoperative pulmonary complications and hospital length of stay
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