AnesthesiaPULCHO-KNEENCT03978169
Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound
An observational study of Anesthesia, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- pleuropulmonary ultrasound
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2018to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing scheduled primary knee arthroplasty
Who may be able to join
- 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
Show all 9Show fewer
- Spinal anaesthesia
- Major Patient
- Oral non opposition collected after oral information of the study
Who cannot join
- Refusal to participate
- Preoperative pleural pathology (pleural effusion, pleural symphysis)
- Pregnancy
- Patient under authorship or curators
- non-affiliation to a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UHToulouse
Toulouse, 31059
Fabrice FERRE, MD, 05 61 77 99 88 ext. +33, ferre.f@chu-toulouse.fr
Fabrice FERRE, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- pleuropulmonary ultrasound
- Keywords
- anaesthetic modality, Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| General anaesthesia with orotracheal intubation | surgery patients under general anaesthesia with orotracheal intubation Receives: Diagnostic Test: pleuropulmonary ultrasound | |
| General anaesthesia with laryngeal mask | surgery patient under general anaesthesia with laryngeal mask Receives: Diagnostic Test: pleuropulmonary ultrasound | |
| Spinal anaesthesia | surgery's patients under Spinal anaesthesia Receives: Diagnostic Test: pleuropulmonary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start13 Dec 2018
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice FERRE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978169
- Sponsor's protocol ID
- RC31/18/0379
- Acronym
- PULCHO-KNEE
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound: A Prospective Study in Scheduled Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03978169
- Acronym / sponsor ID
- PULCHO-KNEE / RC31/18/0379
- Conditions
- Anesthesia
- Keywords
- anaesthetic modality, Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anaesthesia with orotracheal intubation | – | Diagnostic Test: pleuropulmonary ultrasoundsurgery patients under general anaesthesia with orotracheal intubation |
| General anaesthesia with laryngeal mask | – | Diagnostic Test: pleuropulmonary ultrasoundsurgery patient under general anaesthesia with laryngeal mask |
| Spinal anaesthesia | – | Diagnostic Test: pleuropulmonary ultrasoundsurgery's patients under Spinal anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing scheduled primary knee arthroplasty
Key inclusion criteria (9 listed)
- Patient undergoing scheduled primary knee arthroplasty :
- Partial knee replacement surgery
- Total knee replacement surgery
- General anaesthesia with orotracheal intubation
- General anaesthesia with laryngeal mask
Key exclusion criteria (5 listed)
- Refusal to participate
- Preoperative pleural pathology (pleural effusion, pleural symphysis)
- Pregnancy
- Patient under authorship or curators
- non-affiliation to a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleuropulmonary ultrasoundthree pleuro-pulmonary ultrasound scans will be performed, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery | Diagnostic test | General anaesthesia with laryngeal mask, General anaesthesia with orotracheal intubation, Spinal anaesthesia |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice FERRE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrice FERRE, MD (05 61 77 99 88 ext. +33, ferre.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung lesions by the anaesthetic and operative management after knee replacement surgery (time frame: 10 minutes before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.