Deep Breathing Exercise With Incentive Spirometer Started in the Preoperative Period

NCT05428722 | Completed

• 1 other identifier: OnerCengizH
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Open cardiac surgery is an important treatment method that is frequently used in the treatment of complicated atherosclerotic ischemic heart disease and heart valve diseases. It is emphasized that respiratory functions decrease significantly after cardiac surgery, especially in the immediate post-operative period. Therefore, despite significant progress in the field of cardiopulmonary bypass and anesthesia technique, pulmonary complications after cardiac surgery are still seen as the main cause of other negative outcomes such as morbidity, mortality, and long-term hospitalization. Cardiac surgery patients are especially at high risk for the development of postoperative pulmonary complications (PPC). It has been reported that deep breathing exercises improve postoperative lung expansion and ventilation, resulting in a significant reduction in pulmonary complications. Postoperative respiratory physiotherapy techniques include techniques such as early mobilization, positioning, breathing exercises, active breathing techniques cycle, as well as the use of different mechanical devices such as incentive spirometry (IS), positive expiratory pressure mask therapy, and continuous positive airway pressure. Incentive spirometry (IS) is a mechanical breathing device that provides slow deep breathing and gives visual feedback and is used as one of the important interventions in the prevention of PPC in patients who have been undergoing open heart surgery for many years. In studies examining the effectiveness of deep breathing exercise with IS on the development of PPC in open cardiac surgery patients, it is seen that IS application is performed in the postoperative period , it is noteworthy that there is no study examining the effectiveness of preoperative IS application. In the light of this information, the aim of this study is to evaluate the effect of deep breathing exercise with incentive spirometry initiated in the preoperative period on pulmonary function and complications in patients undergoing open heart surgery.

Conditions

Breathing Exercises

Keywords

Cardiac Surgical Procedures; Breathing Exercises; Postoperative Complications

Outcome Measures

Primary Outcomes (31)

• Respiratory rate1

  the respiratory rate will be counted by the research nurse the first day of hospitalization.

  within 24 hours of hospitalization

• Respiratory rate2

  the respiratory rate will be counted by the research nurse the day before surgery.

  up to 24 hours before surgery

• Respiratory rate3

  the respiratory rate will be counted by the research nurse the day after surgery.

  up to 24 hours

• Respiratory rate4

  the respiratory rate will be counted by the research nurse on the day of discharge.

  up to 24 hours

• SpO2 level1

  the SpO2 level of patients will be evaluated the first day of hospitalization.

  within 24 hours of hospitalization

• SpO2 level2

  the SpO2 level of patients will be evaluated the day before surgery.

  up to 24 hours

• SpO2 level3

  the SpO2 level of patients will be evaluated the day after surgery.

  up to 24 hours

• SpO2 level4

  the SpO2 level of patients will be evaluated on the day of discharge.

  up to 24 hours

• Arterial blood gas parameters-pH1

  Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated

  within 24 hours of hospitalization

• Arterial blood gas parameters-O2-1

  Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated

  within 24 hours of hospitalization

• Arterial blood gas parameters-CO2-1

  Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated

  within 24 hours of hospitalization

• Arterial blood gas parameters-saO2-1

  Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated

  within 24 hours of hospitalization

• Arterial blood gas parameters-HCO3-1

  Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated

  within 24 hours of hospitalization

• Arterial blood gas parameters-pH2

  Arterial blood gas parameters of the patients before surgery will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-O2-2

  Arterial blood gas parameters of the patients before surgery will be evaluated

  up to 24 hours

• Arterial blood gas parameters-CO2-2

  Arterial blood gas parameters of the patients before surgery will be evaluated

  up to 24 hours

• Arterial blood gas parameters-saO2-2

  Arterial blood gas parameters of the patients before surgery will be evaluated

  up to 24 hours

• Arterial blood gas parameters-HCO3-2

  Arterial blood gas parameters of the patients before surgery will be evaluated

  up to 24 hours

• Arterial blood gas parameters-pH-3

  Arterial blood gas parameters of the patients postoperative first day will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-pO2-3

  Arterial blood gas parameters of the patients postoperative first day will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-pCO2-3

  Arterial blood gas parameters of the patients postoperative first day will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-psaO2-3

  Arterial blood gas parameters of the patients postoperative first day will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-HCO3

  Arterial blood gas parameters of the patients postoperative first day will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-pH.4

  Arterial blood gas parameters of the patients on the day of discharge will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-pO2.4

  Arterial blood gas parameters of the patients on the day of discharge will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-pCO2.4

  Arterial blood gas parameters of the patients on the day of discharge will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-psaO2.4

  Arterial blood gas parameters of the patients on the day of discharge will be evaluated .

  up to 24 hours

• Arterial blood gas parameters-HCO3.4

  Arterial blood gas parameters of the patients on the day of discharge will be evaluated .

  up to 24 hours

• Posteroanterior chest X-ray-1

  All patients' first PA X-rays taken on the first day of hospitalization will be evaluated by the investigator.

  within 24 hours of hospitalization

• Posteroanterior chest X-ray-2

  All patients' last PA X-rays taken on the day of dischargewill be evaluated by the investigator.

  up to 24 hours

• Postoperative pulmonary complication

  Defined as the occurrence of at least 1 pulmonary complication among atelectasis, pleural effusion, respiratory failure, pneumonia, pneumothorax, bronchospasm, or aspiration pneumonia. The presence of the developing condition, diagnosed by the doctor, was determined as the criterion. This will be evaluated by the Investigator physician and nurse.

  Before discharge (up to 14 days)

Secondary Outcomes (3)

• Length of stay in mechanical ventilation

  up to 24 hours

• Length of stay in intencive care unit(ICU)

  Before discharge ICU (up to 1 day)

• Length of hospitalization

  Before discharge (up to 14 days)

Study Arms (2)

deep breathing group

EXPERIMENTAL

The intervention group is the group in which the investigators applied deep breathing exercises with incentive spirometer starting from the preoperative period.

Behavioral: deep breathing exercises with a incentive spirometer

Control group

NO INTERVENTION

The control group is the group that receives standard clinical care.

Interventions

deep breathing exercises with a incentive spirometer BEHAVIORAL

Deep breathing exercise will be explained to the patients with an incentive spirometer (IS), it will be demonstrated in practice and it will be applied from the first day of hospitalization in addition to routine treatment and care. The patient will be informed about whether they are doing it right and their questions will be answered. It will be ensured that the patients start after breakfast in the morning and make 5-10 inspirations, hold her/his breath for 3 seconds and 5-10 expirations per hour with IS until they fall asleep. The research nurse will warn the patients that they should do the exercise every hour, and the alarms of the patients' mobile phones will be set to ring every hour to be a warning. The start and end time of the exercise will be decided together with the patient, and usually the time of waking and going to bed will be taken into account.

deep breathing group

Eligibility Criteria

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

You may qualify if:

• years and over,
• Able to speak and understand Turkish,
• Conscious, oriented and cooperative,
• First time undergoing cardiac surgery,
• In the Preoperative Chest Diseases Consultation, it was determined that there was no lung pathology and bronchodilator treatment was not started,
• Coronary artery bypass graft (CABG), heart valve surgery or combined open cardiac surgery,
• Having a score of 1 on the Medical Research Council Scale (MRCS),

You may not qualify if:

• Emergency surgical intervention applied,
• Complete (100%) occlusion of the left main coronary (LMCA) or right main coronary artery,
• With concomitant vascular aneurysm,
• Chronic respiratory system disease (Asthma, COPD, bronchiectasis, bullous lung, etc.),
• Those who do not agree to participate in the study,
• Died in the process of working,
• Patients for whom data cannot be collected will be excluded.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Hatice ÖNER CENGİZ

Altındağ, Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Oner Cengiz H, Ulusan Ozkan Z, Gani E. The effect of preoperative deep breathing exercise with incentive spirometer initiated in the preoperative period on respiratory parameters and complications in patients underwent open heart surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Jan 24;25(1):36. doi: 10.1186/s12871-025-02902-9.

  PMID: 39856565 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice ÖNER CENGİZ, PhD.

  Ankara University

  STUDY DIRECTOR

• Zeynep ULUŞAN ÖZKAN, MD

  university of health sciences ankara education and research hospital

  PRINCIPAL INVESTIGATOR

• Eylem GANİ, Nurse

  university of health sciences ankara education and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized conrolled trial in the parallel group

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 23, 2022
• Study Start: June 25, 2022
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

TU (1)