NCT06814054

Brief Summary

In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

February 3, 2025

Last Update Submit

June 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients

    the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.

    immediate preoperative peroid before the induction of general anesthesia

Study Arms (1)

GA induced hypotension in geriatrics

Postinduction hypotension will be defined as either * A 30% drop in SBP or 20% drop in MAP from baseline, or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within three minutes of general anaesthesia induction, every minute until 15 min after endotracheal intubation and before the start of any surgical manipulations. * Since endotracheal intubation and direct laryngoscopy can generate sympathetic activation, which will change blood pressure, we decided to start haemodynamic monitoring three minutes post endotracheal intubation. * If the MAP was less than 65 mmHg, a 250 ml crystalloid bolus will be administered and repeated as necessary. * If hypotension persist after IV fluid bolus, ephedrine will be given by three milligrams. At the end of surgery.

Diagnostic Test: Carotid Artery Corrected Flow Time measurementDiagnostic Test: Inferior vena cava collapsibility index

Interventions

* The cFT is defined as the time between the onset of systolic flow until closure of the aortic valve corrected for the HR and has been found to correlate with the intravascular volume. * carotid ultrasound imaging will be performed 10 minutes before induction of general anesthesia in the preoperative holding area. * Ultrasound measurements will be performed under a vascular setting with a 6.0 to 13.0MHz linear array transducer * The right common carotid artery cFT will be measured in supine position with their heads tilted 30° to the left * After that, a pulse wave Doppler will be chosen, and the sampling frame will be positioned at an angle of less than 60° in the region of the carotid artery with the best color flow to acquire the blood flow spectrum.

GA induced hypotension in geriatrics

* The IVC will be examined while the patient has been spontaneously, quietly breathing and lying in the supine position for at least 5 min before assessment. * A two-dimensional image of the IVC as it entered the right atrium will be obtained through the paramedian long-axis view via a subcostal approach using a curvilinear phased array probe (2-5 MHz) * Then, using M-mode imaging produced at a medium sweep speed, changes in IVC diameter with breathing will be evaluated 2 to 3 cm distal to the right atrium. * During the same respiratory cycle, measurements will be made of the IVC's greatest expiratory diameter (dIVC expiration) and lowest inspiratory diameter (dIVC inspiration). The formula IVCCI = (dIVC expiration - dIVC inspiration) × 100/dIVC expiration will be used to determine IVCCI as a percentage. (12) * IVCCI will be assessed by the same trained anesthesiologist who was blinded to postin duction hemodynamic measurements.

GA induced hypotension in geriatrics

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

geriatric patients (65 years and above) (10) of either sex and ASA PS I to Ⅱ receiving general anesthesia for elective surgery, who fasted for at least 6 to 8 hours were recruited in this study

You may qualify if:

  • American Society of Anaesthesiologists Physical Status I to Ⅱ
  • receiving general anesthesia for elective surgery
  • fasted for at least 6 to 8 hours were recruited in this study

You may not qualify if:

  • patients who refused to participate in the study
  • American Society of Anaesthesiologists Physical Status Ⅲ or Ⅳ
  • Patients with a history of peripheral arterial diseases or atherosclerosis
  • Patients with body mass index of greater than 30 kg/m2
  • Patients with arrhythmia or cardiomyopathy
  • Chronic obstructive pulmonary disease (COPD)
  • baseline systolic arterial pressure (SAP) ≥ 180 mmHg or \< 90mmHg
  • Any episode of desaturation or difficult intubation during general anasethia induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

RECRUITING

Study Officials

  • tarek Mostafa

    tanta university, faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 7, 2025

Study Start

March 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations