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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT06153550
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sternotomy	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 Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Nov 10, 2021
• Actual Study Completion Date: Nov 10, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Analysis of the evolution of the pulmonary function by Forced spirometry. [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

Secondary Outcome Measures

1. Analysis of the evolution of the pulmonary function by Resistance [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

2. Analysis of the evolution of the pulmonary function by Lung volumes [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

3. Analysis of the evolution of the pulmonary function by Dissemination capacity, [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

4. Analysis of the evolution of the pulmonary function by Flow / volume curves [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

5. Analysis of the evolution of the pulmonary function by Peripheral saturation [3 weeks before, the day before and the day after surgery.]

   Measured by spirometry and pulse oximetry results.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Andranik PETROSYAN, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT06153550
• Other Study ID Numbers: IRBN522021/CHUSTE
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Cardiac surgery; Sternotomy; respiration; Spirometry; pulse oximetry

Study Results

No Results Posted as of Dec 1, 2023