The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery

Sternotomy Clinical Trial

Official title:

The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06153550
• Other study ID #: IRBN522021/CHUSTE
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing. There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.

Description:

The aim of the study is to have a quantification of this preparation spirometry: before starting the preparation and at the end of the preparation (right before surgery) by comparing the spirometric and pulse oximetry information. The prospective study will be conducted on 25 patients, who will be selected consecutively without randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient with indication of cardiac surgery

Exclusion Criteria:

• Patient with a Body Mass Index (BMI) > 30
• Restrictive patient
• Obstructive patient
• Asthmatic
• Chronic Obstructive Pulmonary Disease (COPD)
• History of pulmonary fibrosis, tuberculosis
• Coronary patients with stenosis of the common trunk.
• Emergency and lifesaving surgeries
• History of thoracic trauma
• Severe kyphotic patients
• History of radiotherapy
• Patients with neuromuscular disease
• Patients with thoracic cage involvement (pectus excavatum, post thoracic surgery)
• Patients with emphysema
• Patients with dilated bronchi

Related Conditions & MeSH terms

• Sternotomy

Intervention

Other:
• preparation in Respiratory Physiotherapy
preparation in Respiratory Physiotherapy consist to: 3 sessions per week with the physiotherapist spirometry and pulse oximetry test 3 weeks before surgery, the day before surgery and the day after surgery.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the evolution of the pulmonary function by Forced spirometry.	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.
Secondary	Analysis of the evolution of the pulmonary function by Resistance	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.
Secondary	Analysis of the evolution of the pulmonary function by Lung volumes	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.
Secondary	Analysis of the evolution of the pulmonary function by Dissemination capacity,	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.
Secondary	Analysis of the evolution of the pulmonary function by Flow / volume curves	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.
Secondary	Analysis of the evolution of the pulmonary function by Peripheral saturation	Measured by spirometry and pulse oximetry results.	3 weeks before, the day before and the day after surgery.