IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension

NCT ID: NCT04238234

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-05

Study Completion Date

2021-11-01

Brief Summary

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This thesis aims to evaluate the ability of preoperative plethysmographic variability index to predict post-induction hypotension in comparison with ultrasound measurements of inferior vena cava (IVC) diameter.

Detailed Description

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Prospective cohort study. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansteron 4mg) will be administrated.

Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage.

Plethysmographic variability index and a perfusion index readings will be taken preinduction in the form of three readings on one-minute interval.

Induction of anaesthesia will be achieved using propofol (2 mg/Kg) and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anaesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.

Any episode of hypotension (defined as mean arterial pressure \< 80% of the baseline reading) will be managed by 5mcg norepinephrine.

Conditions

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Hypotension on Induction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia.

IVC Ultrasonography

Intervention Type DEVICE

Ultrasound measurements will be performed using a curved transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). IVC variation will be assessed using ultrasound in the long-axis (sagittal) view. IVC diameter will be measured 1 cm distal to its junction with hepatic vein either by 2-D or M modes via a subcostal approach according to the methodology described by the American Society of Echocardiography . A two-dimensional image of the IVC as it enters the right atrium will be first obtained.

Plethysmographic variability index (PVI) and perfusion index readings (PI)

Intervention Type DEVICE

The PVI and PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET ("MightySat 9900, Masimo Corporation, Irvine, CA, USA).

PVI (%) is a measure of the dynamic change in PI that occurs during one or more complete respiratory cycles, calculated as:

PVI= \[(PImax-PImin)/PImax\] x100

Interventions

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IVC Ultrasonography

Ultrasound measurements will be performed using a curved transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). IVC variation will be assessed using ultrasound in the long-axis (sagittal) view. IVC diameter will be measured 1 cm distal to its junction with hepatic vein either by 2-D or M modes via a subcostal approach according to the methodology described by the American Society of Echocardiography . A two-dimensional image of the IVC as it enters the right atrium will be first obtained.

Intervention Type DEVICE

Plethysmographic variability index (PVI) and perfusion index readings (PI)

The PVI and PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET ("MightySat 9900, Masimo Corporation, Irvine, CA, USA).

PVI (%) is a measure of the dynamic change in PI that occurs during one or more complete respiratory cycles, calculated as:

PVI= \[(PImax-PImin)/PImax\] x100

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18years)
* ASA I-II-III
* Patients scheduled for elective surgeries under general anaesthesia.

Exclusion Criteria

* Operations which will last for less than 15 minutes.
* Patients with cardiac morbidities (impaired contractility with ejection fraction \< 40% and tight valvular lesions, unstable angina).
* Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
* Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
* Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
* Patients with peripheral vascular disease or long standing DM affecting PVI readings.
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Bassant M. Abdelhamid

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassant abdelhamid, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr alainy

Cairo, , Egypt

Site Status RECRUITING

Almaza Militrary Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Bassant abdelhamid, M.D.

Role: CONTACT

01224254012

Akram Yassin, MS

Role: CONTACT

010 95 91 71 95

Facility Contacts

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Bassant abdelhamid

Role: primary

01224254012

Mohamed Zedan, MD

Role: primary

01001935006

References

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Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.

Reference Type BACKGROUND
PMID: 30236233 (View on PubMed)

Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.

Reference Type BACKGROUND
PMID: 26771910 (View on PubMed)

Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.

Reference Type BACKGROUND
PMID: 20236098 (View on PubMed)

Other Identifiers

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N-68-2021

Identifier Type: -

Identifier Source: org_study_id

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