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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- Recruiting
- UHToulouse
-
Contact:
- Fabrice FERRE, MD
- Phone Number: +33 05 61 77 99 88
- Email: ferre.f@chu-toulouse.fr
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Principal Investigator:
- Fabrice FERRE, MD
-
Sub-Investigator:
- Laeticia BOSCH, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General anaesthesia with orotracheal intubation
surgery patients under general anaesthesia with orotracheal intubation
|
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
|
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
|
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
Time Frame: 10 minutes before 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
Time Frame: 10 minutes post 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
Time Frame: 24hours post surgery
|
Describe lung lesions by the anaesthetic and operative management after knee replacement surgery
|
24hours post surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC31/18/0379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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