Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery

NCT05470686 | Recruiting

• 1 other identifier: 2022-A01478-35
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation. Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients Secondary objectives

• To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement.
• To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score
• To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio
• To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV
• To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session

Conditions

Heart Surgery

Keywords

heart surgery; Lung ultrasound score; PaO2/FiO2 ration; physiotherapy; Non invasive ventilation

Outcome Measures

Primary Outcomes (2)

• Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)

  The higher the ratio, better is the result. Between approximately 0 and 400

  the morning after the heart surgery

• Difference in lung ultrasound score: measurement after - measurement before the physiotherapy session + non invasive ventilation

  Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows: 0 = normal ventilation 1. = multiple B-lines defined 2. = coalescing B-lines 3. = pulmonary consolidation

  the morning after the heart surgery

Secondary Outcomes (6)

• Lung ultrasound score values obtained by both evaluators from the same recorded ultrasound images. If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.

  in the week following the measurements

• relative difference in PaO2/FiO2 ratio

  the morning after the heart surgery

• difference in lung ultrasound score for each study area

  the morning after the heart surgery

• initial lung ultrasound score

  the morning after the heart surgery

• relative difference in PaCO2

  the morning after the heart surgery and after physiotherapy session

Study Arms (1)

HEART SURGERY PATIENTS with cardio pulmonary bypass

OTHER

Biological: blood gas via arterial catheter

Interventions

blood gas via arterial catheter BIOLOGICAL

Patients will have a blood sample plus a lung ultrasound before and after the physical therapy session combined with non invasive ventilation the morning after the heart surgery

Also known as: Lung ultrasound score

HEART SURGERY PATIENTS with cardio pulmonary bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person having received complete information on the organization of the research and having given written consent to participate
• Person having benefited from a heart surgery under cardio-pulmonary bypass
• Medical prescriptions for non invasive ventilation and physiotherapist
• Age ≥ 18 years
• ≤ BMI ≤ 35 kg/m2
• Visual Analogy Scale pain \< 4
• Patient conscious and oriented: Glasgow 15/15

You may not qualify if:

• At the patient's request : a patient may withdraw from the research at any time without affecting the quality of care to which he or she is entitled (withdrawal of consent).
• Failure of the blood gas analyzer.
• PEEP \> 6 cmH2O required during physiotherapy + non invasive ventilation session
• PEEP \< 6 cmH2O required during physiotherapy + non invasive ventilation session
• Premature interruption of the physiotherapy session + non invasive ventilation not hemodynamically tolerated
• Need for a session of non invasive ventilation + physiotherapy \> 30 minutes.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

centralHNF

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Study Officials

• Jean PAYSANT

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Central Study Contacts

Aurélie roth oudin

CONTACT

03 83 15 41 96; a.roth@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: June 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

FR (1)