Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05558826
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2022-09-25
Brief Title:
Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
Intraoperative fluid management is key component of care for patients undergoing surgery Hypovolemia and hypervolemia both associate with increased morbidity length of stay in the intensive care unit and mortality Thus maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies However dynamic indices of arterial pressure waveform analysis such as pulse pressure variation PPV and stroke volume variation SVV are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position Intravascular fluid status might thus be misinterpreted Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal gynecological and genitourinary procedures Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform
Detailed Description:
In this prospective observational study the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason Anesthetic management and surgery will be performed as usual clinical practice
The investigators will record the digital data exported from standard monitoring instruments including electrocardiography photo-plethysmography blood pressure neurological system information Bispectral index and Density spectral array the respiratory gas monitoring gas analyzer and respiratory waveform and dynamic indices of arterial pressure waveform analysis cardiac index stroke volume variation pulse pressure variation hypotension prediction index etc from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software Edwards Lifesciences every 20 seconds
After anesthesia induction as routine clinical practice slow IV fluid infusion will be maintained The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded The recording is ended after emergence when surgery ends All physiological data and demographic data will be stored in digital media after being de-linked from personal identification
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform Methods including signal processing modeling classification will be used
The investigators will record the digital data exported from standard monitoring instruments including electrocardiography photo-plethysmography blood pressure neurological system information Bispectral index and Density spectral array the respiratory gas monitoring gas analyzer and respiratory waveform and dynamic indices of arterial pressure waveform analysis cardiac index stroke volume variation pulse pressure variation hypotension prediction index etc from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software Edwards Lifesciences every 20 seconds
After anesthesia induction as routine clinical practice slow IV fluid infusion will be maintained The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded The recording is ended after emergence when surgery ends All physiological data and demographic data will be stored in digital media after being de-linked from personal identification
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform Methods including signal processing modeling classification will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None