Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

NCT ID: NCT02343601

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

Detailed Description

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All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Conditions

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Polyp of Large Intestine Colorectal Neoplasms Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Control group using a hemodynamic standard protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Photoplethysmography group

Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)

Group Type OTHER

Photoplethysmography

Intervention Type DEVICE

Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

Interventions

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Photoplethysmography

Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age\> 18 years
* Colorectal surgery

Exclusion Criteria

* Pregnant women
* Black skin
* Chronic renal insufficiency (MDRD \<30 ml/min)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Lise Fiant, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Caen

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

References

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Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4.

Reference Type DERIVED
PMID: 27004412 (View on PubMed)

Other Identifiers

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2014-A00870-47

Identifier Type: -

Identifier Source: org_study_id

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