NCT03974568

Brief Summary

Peripheral perfusion index (PPI) is variable measured by Radical-7 (Masimo) device and reflects the ratio between pulsatile and non-pulsatile portions of peripheral circulation. PPI is characterized by being non-invasive, real time, and simple variable. Impairment of various perfusion indices (such as central venous oxygen saturation and serum lactate) during spontaneous breathing trial (SBT) were previously reported; however, these indices are characterized by being relatively invasive. We hypothesized that impairment of PPI during SBT might be predictive of weaning failure. The aim of this work was to evaluate the possible association between PPI and success of SBT

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

May 31, 2019

Last Update Submit

January 25, 2020

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (1)

  • peripheral perfusion index (PPI) ratio

    PPI by the end of spontaneous breathing trial (SBT) / baseline PPI

    30 minutes

Secondary Outcomes (7)

  • peripheral perfusion index

    30 minutes

  • heart rate

    30 minutes

  • systolic blood pressure

    30 minutes

  • cardiac output

    30 minutes

  • central venous pressure

    30 minutes

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

mechanically ventilated patients for more than 48 hours

You may qualify if:

  • mechanically ventilated patients for more than 48 hours

You may not qualify if:

  • patients \< 18 years
  • patients with peripheral vascular disease
  • patients on vasopressors
  • patients with hand injuries hindering which would preclude the application of the device probe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Lotfy A, Hasanin A, Rashad M, Mostafa M, Saad D, Mahmoud M, Hamimy W, Fouad AZ. Peripheral perfusion index as a predictor of failed weaning from mechanical ventilation. J Clin Monit Comput. 2021 Apr;35(2):405-412. doi: 10.1007/s10877-020-00483-1. Epub 2020 Feb 8.

    PMID: 32036499DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

arterial blood gases (ABG)

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 5, 2019

Study Start

June 6, 2019

Primary Completion

October 6, 2019

Study Completion

October 10, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)