Peripheral Perfusion Index (PPI) as Monitor During Delibe... | NCT03007355

Studies
Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia

NCT03007355

Sponsor

Cairo University

Status

Completed

Last Update Posted

Dec 19, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Monitoring During Deliberate Hypotensive Anesthesia

Interventions

peripheral perfusion index measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Oct 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Dec 26, 2016

First Submission Date that Met QC Criteria

Dec 29, 2016

First Posted Date

Jan 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2018

Last Update Posted Date

Dec 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abeer Ahmed, MD, Lecturer of Anesthesia - Faculty of Medicine, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive new monitoring, can reflect the peripheral perfusion dynamics.

This study is designed to explore the behaviour and trend of PPI during nitroglycerine induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
peripheral perfusion index measurement	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between PPI and T1	correlation of baseline values of PPI and time required to achieve target mean arterial pressure.	start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia

Exclusion Criteria:

Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation defects, renal or hepatic insufficiency, and hypersensitivity to the study drugs will be excluded from the study. Patients receiving vasoactive drugs or beta blockers will be also excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

adult male or females, aged between 18-50 years, ASA class I ans II

Sampling Method

Non-Probability Sample