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

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.

Study Overview

• Status: Completed
• Conditions: Sternotomy
• Intervention / Treatment: Other: preparation in Respiratory Physiotherapy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with indication of cardiac surgery will be included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who have sternotomy; Patients who have sternotomy wll be included. They will have preparation in Respiratory Physiotherapy before sternotomy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Andranik PETROSYAN, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac surgery; Spirometry; pulse oximetry; Sternotomy; respiration
• Other Study ID Numbers: IRBN522021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No