NCT06153550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
Last Updated

December 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 23, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

Cardiac surgerySternotomyrespirationSpirometrypulse oximetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Analysis of the evolution of the pulmonary function by Resistance

    3 weeks before, the day before and the day after surgery.

  • Analysis of the evolution of the pulmonary function by Lung volumes

    3 weeks before, the day before and the day after surgery.

  • Analysis of the evolution of the pulmonary function by Dissemination capacity,

    3 weeks before, the day before and the day after surgery.

  • Analysis of the evolution of the pulmonary function by Flow / volume curves

    3 weeks before, the day before and the day after surgery.

  • Analysis of the evolution of the pulmonary function by Peripheral saturation

    3 weeks before, the day before and the day after surgery.

Study Arms (1)

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

Interventions

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.

Patients who have sternotomy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with indication of cardiac surgery will be included.

You may qualify if:

  • Patient with indication of cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andranik PETROSYAN, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 1, 2023

Study Start

September 1, 2021

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

December 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations