NCT03978169

Brief Summary

A prospective, observational, monocentric study aimed at identifying ultrasound changes in anaesthesia on the pulmonary parenchyma after knee arthroplastic surgery using the LUS score in the preoperative, immediate post-operative (D0) and late post-operative (D1) periods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 13, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

May 28, 2019

Last Update Submit

June 5, 2019

Conditions

Anesthesia

Keywords

anaesthetic modalityLung

Outcome Measures

Primary Outcomes (3)

  • lung lesions by the anaesthetic and operative management after knee replacement surgery

    Describe lung lesions by the anaesthetic and operative management after knee replacement surgery

    10 minutes before surgery

  • lung lesions by the anaesthetic and operative management after knee replacement surgery

    Describe lung lesions by the anaesthetic and operative management after knee replacement surgery

    10 minutes post surgery

  • lung lesions by the anaesthetic and operative management after knee replacement surgery

    Describe lung lesions by the anaesthetic and operative management after knee replacement surgery

    24hours post surgery

Study Arms (3)

General anaesthesia with orotracheal intubation

surgery patients under general anaesthesia with orotracheal intubation

Diagnostic Test: pleuropulmonary ultrasound

General anaesthesia with laryngeal mask

surgery patient under general anaesthesia with laryngeal mask

Diagnostic Test: pleuropulmonary ultrasound

Spinal anaesthesia

surgery's patients under Spinal anaesthesia

Diagnostic Test: pleuropulmonary ultrasound

Interventions

pleuropulmonary ultrasoundDIAGNOSTIC_TEST

three pleuro-pulmonary ultrasound scans will be performed, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery

General anaesthesia with laryngeal maskGeneral anaesthesia with orotracheal intubationSpinal anaesthesia

Eligibility Criteria

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

Patient undergoing scheduled primary knee arthroplasty

You may qualify if:

  • Patient undergoing scheduled primary knee arthroplasty :
  • Partial knee replacement surgery
  • Total knee replacement surgery
  • Type of Anaesthesia
  • General anaesthesia with orotracheal intubation
  • General anaesthesia with laryngeal mask
  • Spinal anaesthesia
  • Major Patient
  • Oral non opposition collected after oral information of the study

You may not qualify if:

  • Refusal to participate
  • Preoperative pleural pathology (pleural effusion, pleural symphysis)
  • Pregnancy
  • Patient under authorship or curators
  • non-affiliation to a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31059, France

RECRUITING

Study Officials

  • Fabrice FERRE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice FERRE, MD

CONTACT

05 61 77 99 88ferre.f@chu-toulouse.fr

LAETITIA BOSCH, MD

CONTACT

05 61 77 99 80bosch.l@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 7, 2019

Study Start

December 13, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

FR(1)