Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
Study NCT ID:
NCT01137500
Status:
WITHDRAWN
Last Update Posted:
2018-08-31
First Post:
2010-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Aortic Diameter During Laparoscopic Surgery
Sponsor:
Royal Surrey County Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Ultrasonic Assessment of Changes in Aortic Diameter During Laparoscopic Surgery
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
host site logistical problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 \& patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Detailed Description:
Purpose and design:This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study.
Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure.
Consent: Informed consent will be gained from each participant.
Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient.
Confidentiality: Caldicott principles will be adhered to.
Conflict of interest: None.
Use of tissue samples in future research: None.
Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study.
Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure.
Consent: Informed consent will be gained from each participant.
Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient.
Confidentiality: Caldicott principles will be adhered to.
Conflict of interest: None.
Use of tissue samples in future research: None.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: