Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound (PULCHO-KNEE)

Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound: A Prospective Study in Scheduled Knee Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Diagnostic test: pleuropulmonary ultrasound

Detailed Description

Post-operative pulmonary complications are responsible from morbidity and mortality close to cardiovascular complications.

Perioperative and post-operative respiratory changes are secondary to anaesthesia (general anaesthesia, elongated position, tidal volume) and to surgery in particular abdominal and cardiothoracic surgery.

Several risk factors related to patients were identified: age, ASA score> 2, functional dependence, chronic obstructive pulmonary disease, congestive heart failure, obesity, smoking.

Pulmonary ultrasound is a simple and rapid means of monitoring, widely used in resuscitation and developing in anaesthesia.

The hypothesis of the study is that anaesthesia and / or ventilation is responsible for lung lesions observable by ultrasound from the recovery room, even after extra-thoracic surgeries.

To do this, it will perform 3 pleuro-pulmonary ultrasound scans, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery. LUS score will be calculated. Preoperative data (morphology, comorbidities), preoperative (ventilation, filling, position, type of anaesthesia - general anaesthesia with intubation or laryngeal mask, spinal anaesthesia- , type of surgery) and postoperative data (constants, oxygen therapy, complications) will be collected.

• Study Type: Observational
• Enrollment (Anticipated): 99

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • UHToulouse
    • Contact: Fabrice FERRE, MD; Phone Number: +33 05 61 77 99 88; Email: ferre.f@chu-toulouse.fr
    • Principal Investigator: Fabrice FERRE, MD
    • Sub-Investigator: Laeticia BOSCH, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing scheduled primary knee arthroplasty

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anaesthesia with orotracheal intubation; surgery patients under general anaesthesia with orotracheal intubation	Diagnostic test: pleuropulmonary ultrasound; 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 mask; surgery patient under general anaesthesia with laryngeal mask	Diagnostic test: pleuropulmonary ultrasound; 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
Spinal anaesthesia; surgery's patients under Spinal anaesthesia	Diagnostic test: pleuropulmonary ultrasound; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2018
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Lung; anaesthetic modality
• Other Study ID Numbers: RC31/18/0379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No