Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound

Anesthesia Clinical Trial

— PULCHO-KNEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978169
• Other study ID #: RC31/18/0379
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: November 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Toulouse
• Contact: Fabrice FERRE, MD
• Phone: 05 61 77 99 88
• Email: ferre.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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