Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

Surgery Clinical Trial

Official title:

Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220906
• Other study ID #: IRB17-00268
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: July 2, 2018

Study information

• Verified date: August 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• ASA status 1-3

• 0-10 years of age

• Undergoing surgical procedure with planned arterial cannula placement

Exclusion Criteria:

• ASA status >3

• Older than 10 years of age

• Patient unable to have BP taken on 1 upper and 1 lower extremity

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Blood pressure measurement
Blood pressure will be measured in both upper and lower extremities.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	King Fahad Medical City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deviation >5 mmHg in MAP	Deviation >5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study.	45 minutes
Secondary	Deviation >10 mmHg	Deviation >10 mmHg between the non-invasive and invasive measurements.	45 minutes