Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04238052
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2020-01-19
Brief Title:
Assessing the Ability of Non-invasive Blood Pressure Measurement in Both Arm for Detecting Hypotension in the Lateral Position
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 devices 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
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 devices 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 mgkg propofol 2 mcgkg fentanyl and 05 mgkg 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
Induction of general anesthesia will be achieved by administration of 2 mgkg propofol 2 mcgkg fentanyl and 05 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None