Assessing the Ability of Non-invasive Blood Pressure Measurement in Both Arm for Detecting Hypotension in the Lateral Position

NCT04238052 | Completed

• 1 other identifier: MS-257-2019
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-invasive Blood Pressure; Hypotension

Outcome Measures

Primary Outcomes (1)

• accuracy of MAP measurement at dependent arm for detectiong intraoperative hypotension at lateral position

  MAP below 70 mmHg

  up to 100 minutes

Secondary Outcomes (7)

• accuracy of MAP measurement at non-dependent arm for detectiong intraoperative hypotension at lateral position

  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

  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

  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

  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

  5 minutes after settling in the lateral position, every 5 minutes for 100 minutes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patients with any of the following morbidities:
• peripheral vascular diseases,
• upper limb operations,
• upper limb scars,
• upper limb deep venous thrombosis, and
• arrhythmias

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34001758 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: January 23, 2020
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

EG (1)