Non-invasive Blood PressureNCT04238052
Assessing the Ability of Non-invasive Blood Pressure Measurement in Both Arm for Detecting Hypotension in the Lateral Position
An observational study of Non-invasive Blood Pressure and Hypotension, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Intra-operative hypotension is linked to increased postoperative morbidity and mortality. Intra-operative MAP below 60-70 mmHg or SBP below 100 mmHg increase the risk of post operative myocardial injury, acute kidney injury and death. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-invasive Blood Pressure, Hypotension
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2020to 12 Mar 2020
- 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 60 years
- All sexes
- Adult
Study population: adult patients (18-60 years), American Society of Anesthesiologist - Physical Status I-II, scheduled for elective non-cardiac surgery under general anesthesia and invasive blood pressure monitoring is part of their intraoperative management
Who may be able to join
- adult patients (18-60 years)
- American Society of Anesthesiologist - Physical Status I-II,
- scheduled for elective non-cardiac surgery under general anesthesia and invasive blood pressure monitoring is part of their intraoperative management
Who cannot join
- Patients with any of the following morbidities:
- peripheral vascular diseases,
- upper limb operations,
- upper limb scars,
- upper limb deep venous thrombosis, and
- arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ability of Non-invasive Blood Pressure Measurement in the Dependent and Non-dependent Upper Extremities for Detecting Intra-operative Hypotension in the Lateral Position
Intra-operative hypotension is linked to increased postoperative morbidity and mortality. Intra-operative MAP below 60-70 mmHg or SBP below 100 mmHg increase the risk of post operative myocardial injury, acute kidney injury and death. accurate measurement of blood pressure is fundamental in proper mangement of intraperative hypotension.
Measurement of arterial blood pressure through an arterial catheter is restricted to patients with major, rapid changes in blood pressure in the operating room as well as the intensive care units. Among non-invasive blood pressure (NIBP) monitors, oscillometric blood pressure measuring technology is considered the standard and the most widely used method in medical practice. In oscillometric blood pressure monitor, a pressure transducer located in the cuff senses the maximal arterial oscillation, which represents the mean arterial pressure, and according to the device's algorithm the systolic and diastolic blood pressure (SBP and DBP) will be calculated.
The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. Many surgical procedures, sometimes major, are conducted in the lateral position; during these operations, the choice of the side for application of the NIBP cuff is a challenging decision with no clear recommendations. The non-dependent upper limb is claimed to be inaccurate measurement site because the cuff position is above the level of the heart. While, the dependent upper limb might be affected by compression of the axilla and the upper arm. No data, to the best of our knowledge are available for the accuracy of NIBP in both upper limbs in the lateral position using the invasive arterial blood pressure (IBP) as a reference for detecting intraoperative hypotension.
Read the detailed description
Preoperatively, the upper limb circumference will be measured at the mid arm, and the NIBP cuff size will be selected according to the recommendations of American Heart Association (cuff length and width will be 80% and 40% of arm circumference respectively) Upon arrival to the operating room, a non-invasive blood pressure (NIBP) reading will be obtained in both upper limbs in supine position. Patients with difference of 10 mmHg or above between both limbs will be excluded from the study.
Induction of general anesthesia will be achieved by administration of 2 mg/kg propofol, 2 mcg/kg fentanyl and 0.5 mg/kg atracurium. A 20 G radial arterial catheter will be inserted in the upper limb which is planned to be dependent. The arterial catheter will be connected to a pressure transducer at the level of the heart. Supine IBP reading will be recorded 5-minutes after intubation of the trachea in the supine position with simultaneous NIBP in both upper limbs at 3-minutes intervals. Five-minutes after settling in the lateral position, NIBP will be obtained alternating between the dependent and non-dependent limbs at 5-minutes intervals till the end of the operation or till reaching a maximum of 10 readings from each side.
The reading of the IBP will be obtained from the contralateral upper limb during inflation of the cuff of the NIBP. Whilst, the reading of the IBP will be obtained from the same upper limb just before the inflation of the cuff of the NIBP
- Conditions
- Non-invasive Blood Pressure, Hypotension
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of MAP measurement at dependent arm for detectiong intraoperative hypotension at lateral position
MAP below 70 mmHg
Measured: up to 100 minutes
Secondary outcomes (7)
accuracy of MAP measurement at non-dependent arm for detectiong intraoperative hypotension at lateral position
MAP below 70 mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
accuracy of SBP measurement at dependent arm for detectiong intraoperative hypotension at lateral position
SBP below 100 mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
accuracy of SBP measurement at non-dependent arm for detecting intraoperative at lateral position
SBP below 100 mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
correlation between NIBP measurement at dependent arm in relation to invasive blood at lateral position pressure
mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
mean bias and agreement between NIBP measurement at dependent arm in relation to invasive blood at lateral position pressure
mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
correlation between NIBP measurement at non-dependent arm in relation to invasive blood at lateral position pressure
mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
mean bias and agreement between NIBP measurement at non-dependent arm in relation to invasive blood at lateral position pressure
mmHg
Measured: 5 minutes after settling in the lateral position, every 5 minutes for 100 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 start23 Jan 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive Blood PressureStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238052
- Sponsor's protocol ID
- MS-257-2019
- Status last verified
- Mar 2020
- First submitted
- 19 Jan 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mostafa M, Hasanin AM, Elsayed OS, Mostafa MM, Sarhan K. Accuracy of oscillometric blood pressure measurement at both arms in the lateral position. Blood Press Monit. 2021 Oct 1;26(5):364-372. doi: 10.1097/MBP.0000000000000546.
PubMed 34001758
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of Non-invasive Blood Pressure Measurement in the Dependent and Non-dependent Upper Extremities for Detecting Intra-operative Hypotension in the Lateral Position
- ClinicalTrials.gov ID
- NCT04238052
- Acronym / sponsor ID
- MS-257-2019
- Conditions
- Non-invasive Blood Pressure, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- 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.
Intra-operative hypotension is linked to increased postoperative morbidity and mortality. Intra-operative MAP below 60-70 mmHg or SBP below 100 mmHg increase the risk of post operative myocardial injury, acute kidney injury and death. accurate measurement of blood pressure is fundamental in proper mangement of intraperative hypotension.
Measurement of arterial blood pressure through an arterial catheter is restricted to patients with major, rapid changes in blood pressure in the operating room as well as the intensive care units. Among non-invasive blood pressure (NIBP) monitors, oscillometric blood pressure measuring technology is considered the standard and the most widely used method in medical practice. In oscillometric blood pressure monitor, a pressure transducer located in the cuff senses the maximal arterial oscillation, which represents the mean arterial pressure, and according to the device's algorithm the systolic and diastolic blood pressure (SBP and DBP) will be calculated.
The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. Many surgical procedures, sometimes major, are conducted in the lateral position; during these operations, the choice of the side for application of the NIBP cuff is a challenging decision with no clear recommendations. The non-dependent upper limb is claimed to be inaccurate measurement site because the cuff position is above the level of the heart. While, the dependent upper limb might be affected by compression of the axilla and the upper arm. No data, to the best of our knowledge are available for the accuracy of NIBP in both upper limbs in the lateral position using the invasive arterial blood pressure (IBP) as a reference for detecting intraoperative hypotension.
Detailed description
Preoperatively, the upper limb circumference will be measured at the mid arm, and the NIBP cuff size will be selected according to the recommendations of American Heart Association (cuff length and width will be 80% and 40% of arm circumference respectively) Upon arrival to the operating room, a non-invasive blood pressure (NIBP) reading will be obtained in both upper limbs in supine position. Patients with difference of 10 mmHg or above between both limbs will be excluded from the study.
Induction of general anesthesia will be achieved by administration of 2 mg/kg propofol, 2 mcg/kg fentanyl and 0.5 mg/kg atracurium. A 20 G radial arterial catheter will be inserted in the upper limb which is planned to be dependent. The arterial catheter will be connected to a pressure transducer at the level of the heart. Supine IBP reading will be recorded 5-minutes after intubation of the trachea in the supine position with simultaneous NIBP in both upper limbs at 3-minutes intervals. Five-minutes after settling in the lateral position, NIBP will be obtained alternating between the dependent and non-dependent limbs at 5-minutes intervals till the end of the operation or till reaching a maximum of 10 readings from each side.
The reading of the IBP will be obtained from the contralateral upper limb during inflation of the cuff of the NIBP. Whilst, the reading of the IBP will be obtained from the same upper limb just before the inflation of the cuff of the NIBP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- adult patients (18-60 years), American Society of Anesthesiologist - Physical Status I-II, scheduled for elective non-cardiac surgery under general anesthesia and invasive blood pressure monitoring is part of their intraoperative management
Key inclusion criteria (3 listed)
- adult patients (18-60 years)
- American Society of Anesthesiologist - Physical Status I-II,
- scheduled for elective non-cardiac surgery under general anesthesia and invasive blood pressure monitoring is part of their intraoperative management
Key exclusion criteria (6 listed)
- peripheral vascular diseases,
- upper limb operations,
- upper limb scars,
- upper limb deep venous thrombosis, and
- arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of MAP measurement at dependent arm for detectiong intraoperative hypotension at lateral position
Time frame: up to 100 minutes
MAP below 70 mmHg
7 secondary outcomes
accuracy of MAP measurement at non-dependent arm for detectiong intraoperative hypotension at lateral position
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
accuracy of SBP measurement at dependent arm for detectiong intraoperative hypotension at lateral position
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
accuracy of SBP measurement at non-dependent arm for detecting intraoperative at lateral position
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
correlation between NIBP measurement at dependent arm in relation to invasive blood at lateral position pressure
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
mean bias and agreement between NIBP measurement at dependent arm in relation to invasive blood at lateral position pressure
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
correlation between NIBP measurement at non-dependent arm in relation to invasive blood at lateral position pressure
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
mean bias and agreement between NIBP measurement at non-dependent arm in relation to invasive blood at lateral position pressure
Time frame: 5 minutes after settling in the lateral position, every 5 minutes for 100 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Derived from this study: PubMed 34001758Mostafa M, Hasanin AM, Elsayed OS, Mostafa MM, Sarhan K. Accuracy of oscillometric blood pressure measurement at both arms in the lateral position. Blood Press Monit. 2021 Oct 1;26(5):364-372. doi: 10.1097/MBP.0000000000000546.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Blood Pressure and Hypotension, run by Kasr El Aini Hospital at 1 site 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 6 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of MAP measurement at dependent arm for detectiong intraoperative hypotension at lateral position (time frame: up to 100 minutes). 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 NCT04238052, which also lists 1 linked publication.
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 19 Mar 2020.