Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04780139
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Walid Nofal, Ain Shams University

Brief Summary:
The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH.

Condition or disease Intervention/treatment
Post-spinal Anesthesia Hypotension Diagnostic Test: Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area

Detailed Description:

The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH. Spinal anaesthesia is frequently used in daily clinical practice. Postspinal anaesthesia hypotension (PSAH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. Patients' susceptibility to intraoperative hypotension can be influenced by the sensory block level, age, preoperative volume status , physical status, pre-operative medications and fasting.

PSAH due to spinal blockade is principally a consequence of diminished systemic vascular resistance after blockade of preganglionic sympathetic fibres. Many attempts have been tried to prevent PSAH, such as intravenous volume preload or prophylactic vasopressors. However, fluid infusion has been proved to lower the incidence of PSAH and significantly decrease vasopressor requirements. At the same time, empirical volume loading carries the potential of volume overload, particularly in patients with cardiac disease. Consequently, the search for predictors of PSAH is becoming mandatory to avoid blind volume loading and reserve it only for patients who are expected to develop PSAH. .

.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021



Intervention Details:
  • Diagnostic Test: Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area
    Measuring the internal jugular vein cross section area and relate this to the incidence of hypotension after spinal anesthesia.


Primary Outcome Measures :
  1. Predictive value of internal jugular vein (IJV) cross sectional area. [ Time Frame: 30 minutes ]
    The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients more than 40 years of age with American Society of Anesthesiologists' (ASA) physical status 1 or 2 who will be scheduled for elective orthopedic surgery under spinal anaesthesia in the supine position
Criteria

Inclusion Criteria:

  • patients more than 40 years of age with American Society of Anesthesiologists' (ASA) physical status 1 or 2 who will be scheduled for elective surgery under spinal anaesthesia in the supine position.

Exclusion Criteria:

  • BMI more than 35 kg m2 , taking angiotensin converting enzyme inhibitors, pregnant women, emergency cases, absolute or relative contraindications to spinal anaesthesia, Also, patients with a baseline arterial systolic blood pressure less than 90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780139


Contacts
Layout table for location contacts
Contact: WALID Nofal, MD 01097121743 w201077@yahoo.com

Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Sanaa Farag Mahmoud, MD Anesthesiology Department, Faculty of Medicine, Ain Shams University
Principal Investigator: Eman Sabek, MD Radiology department, National Centre of Radiation Research and Technology, Atomic Energy Authority
Principal Investigator: WALID Nofal, MD Anesthesiology department, Faculty of Medicine, Ain Shams Unive
Layout table for additonal information
Responsible Party: Walid Nofal, Assisstant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04780139    
Other Study ID Numbers: FMASU R 25/2020/2021
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walid Nofal, Ain Shams University:
internal jugular vein
ultrasound
spinal anesthesia
Hypotension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases