Descending Aorta Blood Flow to Guide Fluid Therapy During Surgery

NCT05227729 | Completed

• 1 other identifier: 264472
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and to explore the variability of hemodynamic variables during surgery.

Conditions

Hemodynamic Instability

Keywords

Hemodynamics; Blood Circulation; Aorta, Thoracic

Outcome Measures

Primary Outcomes (3)

• Change in blood flow velocity in descending aorta

  Suprasternal Doppler

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

• Change in blood flow velocity in descending aorta

  Transoesophageal Doppler

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

• Change in stroke volume

  Calculated from the measurements by transoesophageal Doppler

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

Secondary Outcomes (3)

• Change in heart rate

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

• Change in systemic vascular resistance

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

• Change in blood pressure

  During surgery, every 5 minutes. At least over a time period of 1,5 hours

Study Arms (1)

Patients undergoing abdominal surgery

Inclusion criteria: \> 18 years old, American Society of Anesthesiologists physical status 1-3, abdominal surgery of \> 1,5 hrs estimated duration, no contraindications to the use of oesophageal ultrasound.

Diagnostic Test: Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique; Diagnostic Test: Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler technique

Interventions

Measurement of blood flow in descending aorta by suprasternal ultrasound Doppler technique DIAGNOSTIC_TEST

While study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min.

Patients undergoing abdominal surgery

Measurement of blood flow in descending aorta by transoesophageal ultrasound Doppler technique DIAGNOSTIC_TEST

While study subjects are in general anesthesia the investigator will perform repeated measurements every 5 min.

Patients undergoing abdominal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that plan to undergo abdominal surgery (gastrointestinal or gynecological) at Telemark hospital, Skien, Norway.

You may qualify if:

• Patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 h estimated duration.
• The patients should be of American Society of Anesthesiologists physical status 1-3

You may not qualify if:

• Pathology in the larynx, oesophagus or stomach
• Former surgery in larynx, oesophagus or stomach
• Thoracic aortic aneurysm.

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Telemark Hospital Trust

Skien, Vestfold Og Telemark, 3710, Norway

Location

Study Officials

• Torkjell Nøstdahl, MD, PhD

  Telemark Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 7, 2022
• Study Start: October 18, 2022
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

NO (1)