PACU Stay After Lower Limb Revascularisation

April 25, 2017 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark

Perioperative Mechanisms for Postoperative Function - Case of Lower Extremities Revascularisation

This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As above

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, abdominal center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study includes every patients who undergo revascularisation surgery of one or both of lower extremeties to regain blood perfusion and relieve symptoms. The surgeries in question are for instance bypass, thrombectomy/embolectomy and thromboendarterectomy. The patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.

Description

Inclusion Criteria:

  • Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg.
  • Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass.

Exclusion Criteria:

  • Only PTA intervention
  • Only thrombolysis intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complications assessed by aldrete score
Time Frame: up to 7 days
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Eske K Aasvang, DMSci, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PACU revascularisation 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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