Changes in Aortic Diameter During Laparoscopic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Royal Surrey County Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Royal Surrey County Hospital
ClinicalTrials.gov Identifier:
NCT01137500
First received: June 3, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition
Abdominal Aortic Diameter During Laparoscopic Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonic Assessment of Changes in Aortic Diameter During Laparoscopic Surgery

Further study details as provided by Royal Surrey County Hospital:

Estimated Enrollment: 100
Study Start Date: August 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital

Exclusion Criteria:

  • Patient refusal
  • Surgical refusal
  • Conversion to an open procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137500

Contacts
Contact: Matthew C Dickinson, MB BS +441483464116 matthew.dickinson@gmail.com
Contact: Mike Scott, MB BS +441483464116 mjpscott@hotmail.com

Locations
United Kingdom
Royal Surrey County Hospital Not yet recruiting
Guildford, Surrey, United Kingdom, GU27xx
Contact: Mike Scott, MB BS    +441483464116    mjpscott@hotmail.com   
Sub-Investigator: Fred van Damme, MB ChB         
Sponsors and Collaborators
Royal Surrey County Hospital
Investigators
Principal Investigator: Matthew C Dickinson, MB BS Royal Surrey County Hospital
Study Director: Mike Scott, MB BS Royal Surrey County Hospital
  More Information

No publications provided

Responsible Party: Dr Mike Scott, Royal Surrey County Hospital
ClinicalTrials.gov Identifier: NCT01137500     History of Changes
Other Study ID Numbers: RSCHanaes001
Study First Received: June 3, 2010
Last Updated: June 3, 2010
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on October 30, 2014