SurgeryNCT03547401
Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia
An observational study of Surgery, run by Philippe VAN DER LINDEN at 1 site in Belgium.
Trial summary
Brachial non-invasive blood pressure (NIBP) monitoring is recommended as part of the American Society of Anesthesiology (ASA) basic monitoring package. Although brachial NIBP is often practical, some surgeries and patients may require NIBP measurement elsewhere (e.g. the ankle). Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Surgery
- What is being tested?
- Ankle Non-invasive Blood pressure measurement and Arm Non-invasive Blood pressure measurement
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2018to 5 Sep 2018
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient undergoing elective surgery requiring general anesthesia in supine position. American Society of Anesthesiology (ASA) pysical status score 1.
Who may be able to join
- American Society of Anesthesiology (ASA) pysical status score 1
- Patient undergoing elective surgery requiring general anesthesia in supine position
Who cannot join
- Patient refusal
- systemic pathology
- Body mass index (BMI) superior to 30
- Surgeon requiring a position other than supine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia: a Prospective Cohort Observational Study in Young Healthy Patients
Brachial non-invasive blood pressure (NIBP) monitoring is recommended as part of the American Society of Anesthesiology (ASA) basic monitoring package. Although brachial NIBP is often practical, some surgeries and patients may require NIBP measurement elsewhere (e.g. the ankle).
Several studies have shown that ankle NIBP overestimates brachial NIBP measurements. Algorithms have been proposed, based on correlation studies, to estimate brachial NIBP from ankle NIBP during general anesthesia and mechanical ventilation. These algorithms, however, are based on both heterogeneous populations and surgeries.
Our aim was to determine if ankle brachial NIBP difference occurs in in young ASA physical status 1 patients undergoing general anesthesia in the supine position. We also aim to determine if this difference is constant during anesthesia or if it varies according to different predefined time points.
- Conditions
- Surgery
- Being tested
- Ankle Non-invasive Blood pressure measurement, Arm Non-invasive Blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Non-invasive Blood pressure measurementDevice
Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).
Arm Non-invasive Blood pressure measurementDevice
Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Patient (15 to 40 years old) undergoing elective surgery requiring general anesthesia in supine position. Receives: Device: Ankle Non-invasive Blood pressure measurement; Device: Arm Non-invasive Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial non-invasive blood pressure difference - time point 1
Difference between the non-invasive blood pressure measured at the ankle and at the arm, before induction of anesthesia
Measured: 1 day
Ankle Brachial non-invasive blood pressure difference - time point 2
Difference between the non-invasive blood pressure measured at the ankle and at the arm, after induction of anesthesia
Measured: 1 day
Ankle Brachial non-invasive blood pressure difference - time point 3
Difference between the non-invasive blood pressure measured at the ankle and at the arm, after securing airway
Measured: 1 day
Ankle Brachial non-invasive blood pressure difference - time point 4
Difference between the non-invasive blood pressure measured at the ankle and at the arm, at surgical incision
Measured: 1 day
Ankle Brachial non-invasive blood pressure difference - time point 5
Difference between the non-invasive blood pressure measured at the ankle and at the arm, 10 minutes after surgical incision
Measured: 1 day
Ankle Brachial non-invasive blood pressure difference - time point 6
Difference between the non-invasive blood pressure measured at the ankle and at the arm, at reversal of anesthesia
Measured: 1 day
Secondary outcomes (3)
Pain at the arm (yes/no)
Answer 'yes' or 'no' to the question 'pain at the arm' in postoperative period
Measured: 1 day
Pain at the ankle (yes/no)
Answer 'yes' or 'no' to the question 'pain at the ankle' in postoperative period
Measured: 1 day
Ankle Brachial NIBP difference variation
Determine if Ankle Brachial NIBP difference remains constant or varies during different intraoperative periods
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Aug 2018
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
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 SurgeryStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippe VAN DER LINDEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe VAN DER LINDEN, Brugmann University Hospital
- Investigators
- Sean Coeckelenbergh, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547401
- Sponsor's protocol ID
- CHUB-ABI
- Status last verified
- Sep 2018
- First submitted
- 24 May 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilkes JM, DiPalma JA. Brachial blood pressure monitoring versus ankle monitoring during colonoscopy. South Med J. 2004 Oct;97(10):939-41. doi: 10.1097/01.SMJ.0000129929.28792.77.
PubMed 15558917Drake MJ, Hill JS. Observational study comparing non-invasive blood pressure measurement at the arm and ankle during caesarean section. Anaesthesia. 2013 May;68(5):461-6. doi: 10.1111/anae.12194. Epub 2013 Mar 11.
PubMed 23480469Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
PubMed 23159553
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia: a Prospective Cohort Observational Study in Young Healthy Patients
- ClinicalTrials.gov ID
- NCT03547401
- Acronym / sponsor ID
- CHUB-ABI
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Philippe VAN DER LINDENUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Brachial non-invasive blood pressure (NIBP) monitoring is recommended as part of the American Society of Anesthesiology (ASA) basic monitoring package. Although brachial NIBP is often practical, some surgeries and patients may require NIBP measurement elsewhere (e.g. the ankle).
Several studies have shown that ankle NIBP overestimates brachial NIBP measurements. Algorithms have been proposed, based on correlation studies, to estimate brachial NIBP from ankle NIBP during general anesthesia and mechanical ventilation. These algorithms, however, are based on both heterogeneous populations and surgeries.
Our aim was to determine if ankle brachial NIBP difference occurs in in young ASA physical status 1 patients undergoing general anesthesia in the supine position. We also aim to determine if this difference is constant during anesthesia or if it varies according to different predefined time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Device: Ankle Non-invasive Blood pressure measurement, Device: Arm Non-invasive Blood pressure measurementPatient (15 to 40 years old) undergoing elective surgery requiring general anesthesia in supine position. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient undergoing elective surgery requiring general anesthesia in supine position. American Society of Anesthesiology (ASA) pysical status score 1.
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) pysical status score 1
- Patient undergoing elective surgery requiring general anesthesia in supine position
Key exclusion criteria (4 listed)
- Patient refusal
- systemic pathology
- Body mass index (BMI) superior to 30
- Surgeon requiring a position other than supine
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 |
|---|---|---|
| Ankle Non-invasive Blood pressure measurementNon-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated). | Device | General anesthesia |
| Arm Non-invasive Blood pressure measurementNon-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated). | Device | General anesthesia |
Primary outcome
Ankle Brachial non-invasive blood pressure difference - time point 1
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, before induction of anesthesia
Ankle Brachial non-invasive blood pressure difference - time point 2
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, after induction of anesthesia
Ankle Brachial non-invasive blood pressure difference - time point 3
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, after securing airway
Ankle Brachial non-invasive blood pressure difference - time point 4
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, at surgical incision
Ankle Brachial non-invasive blood pressure difference - time point 5
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, 10 minutes after surgical incision
Ankle Brachial non-invasive blood pressure difference - time point 6
Time frame: 1 day
Difference between the non-invasive blood pressure measured at the ankle and at the arm, at reversal of anesthesia
3 secondary outcomes
Pain at the arm (yes/no)
Time frame: 1 day
Pain at the ankle (yes/no)
Time frame: 1 day
Ankle Brachial NIBP difference variation
Time frame: 1 day
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 12 Sep 2018.
- Background: PubMed 15558917Wilkes JM, DiPalma JA. Brachial blood pressure monitoring versus ankle monitoring during colonoscopy. South Med J. 2004 Oct;97(10):939-41. doi: 10.1097/01.SMJ.0000129929.28792.77.
- Background: PubMed 23480469Drake MJ, Hill JS. Observational study comparing non-invasive blood pressure measurement at the arm and ankle during caesarean section. Anaesthesia. 2013 May;68(5):461-6. doi: 10.1111/anae.12194. Epub 2013 Mar 11.
- Background: PubMed 23159553Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
Sean Coeckelenbergh, MD principal investigator
CHU Brugmann
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 Surgery, run by Philippe VAN DER LINDEN at 1 site in Belgium.
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 2 inclusion and 4 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 12 Sep 2018. 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 Belgium. 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?
Ankle Brachial non-invasive blood pressure difference - time point 1 (time frame: 1 day). The study lists 6 primary outcomes in all. 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 NCT03547401, 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 12 Sep 2018.