Hypotension on InductionNCT04238234
IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension
An observational study of Hypotension on Induction, run by Cairo University at 2 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- IVC Ultrasonography and Plethysmographic variability index (PVI) and perfusion index readings (PI)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Aug 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.
Who may be able to join
- Adult patients (>18years)
- ASA I-II-III
- Patients scheduled for elective surgeries under general anaesthesia.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Kasr alainy
Cairo, 1772
Bassant abdelhamid, 01224254012, bassantmohamed197@yahoo.com
- Recruiting
Almaza Militrary Hospital
Cairo
Mohamed Zedan, MD, 01001935006, mohammedzedan999@gmail.com
About this study
Official title: Comparison of Ultrasound-based Measures of Inferior Vena Cava and Plethysmographic Variability Index for Prediction of Hypotension During Induction of General Anesthesia; Prospective Cohort Study.
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.
Read the detailed description
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
- Hypotension on Induction
- Being tested
- IVC Ultrasonography, Plethysmographic variability index (PVI) and perfusion index readings (PI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC UltrasonographyDevice
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)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
| Study group | Role | What they receive |
|---|---|---|
| study group | Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia. Receives: Device: IVC Ultrasonography; Device: Plethysmographic variability index (PVI) and perfusion index readings (PI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension
Maximum and minimum IVC diameters over a single respiratory cycle will be measured using a built-in software.
The CI will be calculated as:
CI = (dIVCmax - dIVCmin)/dIVCmax CI will be expressed as a percentage
Measured: 10 minutes before general anesthesia
Secondary outcomes (4)
Plethysmographic variability index (PVI) and a perfusion index readings (PI)
Three readings, on one-minute interval before general anesthesia induction
Measured: 3 minutes
Maximum and minimum IVC diameters
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.
Measured: 10 minutes
Mean arterial blood pressure
measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision
Measured: 20 minutes
Heart rate
measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start5 Aug 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238234
- Sponsor's protocol ID
- N-68-2021
- Status last verified
- Oct 2021
- First submitted
- 20 Jan 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30236233Zhang 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.
PubMed 26771910Tsuchiya 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.
PubMed 20236098
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-based Measures of Inferior Vena Cava and Plethysmographic Variability Index for Prediction of Hypotension During Induction of General Anesthesia; Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04238234
- Acronym / sponsor ID
- N-68-2021
- Conditions
- Hypotension on Induction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: IVC Ultrasonography, Device: Plethysmographic variability index (PVI) and perfusion index readings (PI)Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.
Key inclusion criteria (3 listed)
- Adult patients (>18years)
- ASA I-II-III
- Patients scheduled for elective surgeries under general anaesthesia.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVC UltrasonographyUltrasound 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. | Device | study group |
| 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 | Device | study group |
Primary outcome
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension
Time frame: 10 minutes before general anesthesia
Maximum and minimum IVC diameters over a single respiratory cycle will be measured using a built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax CI will be expressed as a percentage
4 secondary outcomes
Plethysmographic variability index (PVI) and a perfusion index readings (PI)
Time frame: 3 minutes
Maximum and minimum IVC diameters
Time frame: 10 minutes
Mean arterial blood pressure
Time frame: 20 minutes
Heart rate
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 30236233Wesselink 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.
- Background: PubMed 26771910Zhang 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.
- Background: PubMed 20236098Tsuchiya 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant abdelhamid, M.D. principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassant abdelhamid, M.D. (01224254012, bassantmohamed197@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension (time frame: 10 minutes before general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238234, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.