Breathing ExercisesNCT05428722
Deep Breathing Exercise With Incentive Spirometer Started in the Preoperative Period
A study testing deep breathing exercises with a incentive spirometer in people with Breathing Exercises, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- deep breathing exercises with a incentive spirometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2022to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Deep Breathing Exercise With Incentive Spirometer Started in the Preoperative Period in Patients Undergoing Open Cardiac Surgery on Pulmonary Function and Complications: A Randomized Controlled Study
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.
Read more
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.
Read the detailed description
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. Complications after cardiac surgery include; supraventricular tachycardia, atrial fibrillation, bradycardia, perioperative myocardial infarction, cardiac arrest, Postoperative pulmonary complications (PPC) such as pneumonia, atelectasis and pleural effusion . 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 PPC. In approximately one-quarter of patients who undergo cardiac surgery without chronic respiratory dysfunction, a mild respiratory tract infection develops ranging from oxygen therapy to acute respiratory failure requiring invasive or non-invasive mechanical ventilation support. Among the factors that cause the development of PPC; surgical stress and anesthesia, cardiopulmonary bypass causing a systemic inflammatory response and oxidative stress that causes pulmonary ischemia-reperfusion injury, type of surgery, pain management, anesthesia protocol, use of blood products, and diaphragmatic dysfunction.
Despite advances in surgical technique and pre- and postoperative care practices in cardiac surgery, PPC is still an important problem. PPC, cost of patient care, increased morbidity and mortality and length of hospital stay elongation. Due to the absence of effective deep inspiration and coughing due to postoperative pain and anxiety, secretion accumulation and gas exchange are ineffective. In a study, it was determined that after coronary artery bypass graft (CABG), 1-20% of patients were hospitalized again in the first 30 days after discharge due to respiratory system complications and 0.4-22.5% of pleural effusion. Various respiratory physiotherapy methods are used for the prevention and treatment of PPC after cardiac surgery. The main purpose of respiratory physiotherapy is to improve ventilation-perfusion compatibility, increase lung volume, increase mucociliary clearance and reduce pain. 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. Deep breathing exercise training with IS is given to the patients in the preoperative period, and its application is started in the postoperative period. However, it has been reported that insufficiency of physical adaptation and respiratory muscle weakness in the preoperative period are closely related to PPC, which causes prolonged hospital stay and increased mortality. In a meta-analysis study examining the effectiveness of preoperative exercise training for the prevention of PPC in adults undergoing major surgery, it was found that preoperative exercise training minimizes the use of hospital resources, improves physical fitness, and reduces the risk of developing PPC, regardless of the type of surgery. In a meta-analysis study examining the effectiveness of preoperative and postoperative rehabilitation in patients with lung cancer, it was determined that preoperative rehabilitation was effective in reducing postoperative pulmonary complications and hospital stay associated with lung cancer surgery. In studies examining the effectiveness of deep breathing exercise with IS on the development of PPC in 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.
Research Hypotheses H1: Oxygen saturation measured using the pulse oximeter TBY200 will be significantly higher in patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period.
H2: Arterial blood gas parameters (pH: 7.35-7.45, PaCO2:35-45 mmHg PaO2:80-100 mmHg, SaO2: 95-97%, HCO3:22-26 mEq/L) in patients who underwent open heart surgery and started deep breathing exercise with IS in the preoperative period will have significantly more normal values.
H3: Postoperative pulmonary complications will develop significantly less in patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period.
H4: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the duration of mechanical ventilation will be significantly shorter.
H5: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the length of stay in the intensive care unit will be significantly shorter.
H6: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the postoperative hospital stay will be significantly shorter.
- Conditions
- Breathing Exercises
- Being tested
- deep breathing exercises with a incentive spirometer
- Keywords
- Cardiac Surgical Procedures, Breathing Exercises, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep breathing exercises with a incentive spirometerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: deep breathing exercises with a incentive spirometer |
| Control group | No intervention | The control group is the group that receives standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate1
the respiratory rate will be counted by the research nurse the first day of hospitalization.
Measured: within 24 hours of hospitalization
Respiratory rate2
the respiratory rate will be counted by the research nurse the day before surgery.
Measured: up to 24 hours before surgery
Respiratory rate3
the respiratory rate will be counted by the research nurse the day after surgery.
Measured: up to 24 hours
Respiratory rate4
the respiratory rate will be counted by the research nurse on the day of discharge.
Measured: up to 24 hours
SpO2 level1
the SpO2 level of patients will be evaluated the first day of hospitalization.
Measured: within 24 hours of hospitalization
SpO2 level2
the SpO2 level of patients will be evaluated the day before surgery.
Measured: up to 24 hours
SpO2 level3
the SpO2 level of patients will be evaluated the day after surgery.
Measured: up to 24 hours
SpO2 level4
the SpO2 level of patients will be evaluated on the day of discharge.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 24 hours of hospitalization
Arterial blood gas parameters-pH2
Arterial blood gas parameters of the patients before surgery will be evaluated .
Measured: up to 24 hours
Arterial blood gas parameters-O2-2
Arterial blood gas parameters of the patients before surgery will be evaluated
Measured: up to 24 hours
Arterial blood gas parameters-CO2-2
Arterial blood gas parameters of the patients before surgery will be evaluated
Measured: up to 24 hours
Arterial blood gas parameters-saO2-2
Arterial blood gas parameters of the patients before surgery will be evaluated
Measured: up to 24 hours
Arterial blood gas parameters-HCO3-2
Arterial blood gas parameters of the patients before surgery will be evaluated
Measured: up to 24 hours
Arterial blood gas parameters-pH-3
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Measured: up to 24 hours
Arterial blood gas parameters-pO2-3
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Measured: up to 24 hours
Arterial blood gas parameters-pCO2-3
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Measured: up to 24 hours
Arterial blood gas parameters-psaO2-3
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Measured: up to 24 hours
Arterial blood gas parameters-HCO3
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before discharge (up to 14 days)
Secondary outcomes (3)
Length of stay in mechanical ventilation
The time from the moment the patients are intubated until they are extubated will be recorded in "hours".
Measured: up to 24 hours
Length of stay in intencive care unit(ICU)
The time from the moment the patients are ICU. It will be recorded in "days".
Measured: Before discharge ICU (up to 1 day)
Length of hospitalization
Postoperative stay will be calculated in days from the first postoperative day. This will be evaluated by the investigative nurse. It will be recorded in "days"
Measured: Before discharge (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start25 Jun 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized conrolled trial in the parallel group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice ÖNER CENGİZ, Ankara University
- Investigators
- Hatice ÖNER CENGİZ, PhD., Study director, Ankara UniversityZeynep ULUŞAN ÖZKAN, MD, Principal investigator, university of health sciences ankara education and research hospitalEylem GANİ, Nurse, Principal investigator, university of health sciences ankara education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428722
- Sponsor's protocol ID
- OnerCengizH
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39856565
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Breathing Exercise With Incentive Spirometer Started in the Preoperative Period in Patients Undergoing Open Cardiac Surgery on Pulmonary Function and Complications: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05428722
- Acronym / sponsor ID
- OnerCengizH
- Conditions
- Breathing Exercises
- Keywords
- Cardiac Surgical Procedures, Breathing Exercises, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Complications after cardiac surgery include; supraventricular tachycardia, atrial fibrillation, bradycardia, perioperative myocardial infarction, cardiac arrest, Postoperative pulmonary complications (PPC) such as pneumonia, atelectasis and pleural effusion . 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 PPC. In approximately one-quarter of patients who undergo cardiac surgery without chronic respiratory dysfunction, a mild respiratory tract infection develops ranging from oxygen therapy to acute respiratory failure requiring invasive or non-invasive mechanical ventilation support. Among the factors that cause the development of PPC; surgical stress and anesthesia, cardiopulmonary bypass causing a systemic inflammatory response and oxidative stress that causes pulmonary ischemia-reperfusion injury, type of surgery, pain management, anesthesia protocol, use of blood products, and diaphragmatic dysfunction.
Despite advances in surgical technique and pre- and postoperative care practices in cardiac surgery, PPC is still an important problem. PPC, cost of patient care, increased morbidity and mortality and length of hospital stay elongation. Due to the absence of effective deep inspiration and coughing due to postoperative pain and anxiety, secretion accumulation and gas exchange are ineffective. In a study, it was determined that after coronary artery bypass graft (CABG), 1-20% of patients were hospitalized again in the first 30 days after discharge due to respiratory system complications and 0.4-22.5% of pleural effusion. Various respiratory physiotherapy methods are used for the prevention and treatment of PPC after cardiac surgery. The main purpose of respiratory physiotherapy is to improve ventilation-perfusion compatibility, increase lung volume, increase mucociliary clearance and reduce pain. 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. Deep breathing exercise training with IS is given to the patients in the preoperative period, and its application is started in the postoperative period. However, it has been reported that insufficiency of physical adaptation and respiratory muscle weakness in the preoperative period are closely related to PPC, which causes prolonged hospital stay and increased mortality. In a meta-analysis study examining the effectiveness of preoperative exercise training for the prevention of PPC in adults undergoing major surgery, it was found that preoperative exercise training minimizes the use of hospital resources, improves physical fitness, and reduces the risk of developing PPC, regardless of the type of surgery. In a meta-analysis study examining the effectiveness of preoperative and postoperative rehabilitation in patients with lung cancer, it was determined that preoperative rehabilitation was effective in reducing postoperative pulmonary complications and hospital stay associated with lung cancer surgery. In studies examining the effectiveness of deep breathing exercise with IS on the development of PPC in 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.
Research Hypotheses H1: Oxygen saturation measured using the pulse oximeter TBY200 will be significantly higher in patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period.
H2: Arterial blood gas parameters (pH: 7.35-7.45, PaCO2:35-45 mmHg PaO2:80-100 mmHg, SaO2: 95-97%, HCO3:22-26 mEq/L) in patients who underwent open heart surgery and started deep breathing exercise with IS in the preoperative period will have significantly more normal values.
H3: Postoperative pulmonary complications will develop significantly less in patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period.
H4: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the duration of mechanical ventilation will be significantly shorter.
H5: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the length of stay in the intensive care unit will be significantly shorter.
H6: In patients undergoing open heart surgery and initiating deep breathing exercise with IS in the preoperative period, the postoperative hospital stay will be significantly shorter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized conrolled trial in the parallel group
| Arm | Type | Receives |
|---|---|---|
| deep breathing group | Experimental | Behavioral: deep breathing exercises with a incentive spirometerThe intervention group is the group in which the investigators applied deep breathing exercises with incentive spirometer starting from the preoperative period. |
| Control group | No intervention | –The control group is the group that receives standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep breathing exercises with a incentive spirometerDeep 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. | Behavioural | deep breathing group |
Primary outcome
Respiratory rate1
Time frame: within 24 hours of hospitalization
the respiratory rate will be counted by the research nurse the first day of hospitalization.
Respiratory rate2
Time frame: up to 24 hours before surgery
the respiratory rate will be counted by the research nurse the day before surgery.
Respiratory rate3
Time frame: up to 24 hours
the respiratory rate will be counted by the research nurse the day after surgery.
Respiratory rate4
Time frame: up to 24 hours
the respiratory rate will be counted by the research nurse on the day of discharge.
SpO2 level1
Time frame: within 24 hours of hospitalization
the SpO2 level of patients will be evaluated the first day of hospitalization.
SpO2 level2
Time frame: up to 24 hours
the SpO2 level of patients will be evaluated the day before surgery.
SpO2 level3
Time frame: up to 24 hours
the SpO2 level of patients will be evaluated the day after surgery.
SpO2 level4
Time frame: up to 24 hours
the SpO2 level of patients will be evaluated on the day of discharge.
Arterial blood gas parameters-pH1
Time frame: within 24 hours of hospitalization
Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated
Arterial blood gas parameters-O2-1
Time frame: within 24 hours of hospitalization
Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated
Arterial blood gas parameters-CO2-1
Time frame: within 24 hours of hospitalization
Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated
Arterial blood gas parameters-saO2-1
Time frame: within 24 hours of hospitalization
Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated
Arterial blood gas parameters-HCO3-1
Time frame: within 24 hours of hospitalization
Arterial blood gas parameters of the patients on the first day of hospitalization will be evaluated
Arterial blood gas parameters-pH2
Time frame: up to 24 hours
Arterial blood gas parameters of the patients before surgery will be evaluated .
Arterial blood gas parameters-O2-2
Time frame: up to 24 hours
Arterial blood gas parameters of the patients before surgery will be evaluated
Arterial blood gas parameters-CO2-2
Time frame: up to 24 hours
Arterial blood gas parameters of the patients before surgery will be evaluated
Arterial blood gas parameters-saO2-2
Time frame: up to 24 hours
Arterial blood gas parameters of the patients before surgery will be evaluated
Arterial blood gas parameters-HCO3-2
Time frame: up to 24 hours
Arterial blood gas parameters of the patients before surgery will be evaluated
Arterial blood gas parameters-pH-3
Time frame: up to 24 hours
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Arterial blood gas parameters-pO2-3
Time frame: up to 24 hours
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Arterial blood gas parameters-pCO2-3
Time frame: up to 24 hours
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Arterial blood gas parameters-psaO2-3
Time frame: up to 24 hours
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Arterial blood gas parameters-HCO3
Time frame: up to 24 hours
Arterial blood gas parameters of the patients postoperative first day will be evaluated .
Arterial blood gas parameters-pH.4
Time frame: up to 24 hours
Arterial blood gas parameters of the patients on the day of discharge will be evaluated .
Arterial blood gas parameters-pO2.4
Time frame: up to 24 hours
Arterial blood gas parameters of the patients on the day of discharge will be evaluated .
Arterial blood gas parameters-pCO2.4
Time frame: up to 24 hours
Arterial blood gas parameters of the patients on the day of discharge will be evaluated .
Arterial blood gas parameters-psaO2.4
Time frame: up to 24 hours
Arterial blood gas parameters of the patients on the day of discharge will be evaluated .
Arterial blood gas parameters-HCO3.4
Time frame: up to 24 hours
Arterial blood gas parameters of the patients on the day of discharge will be evaluated .
Posteroanterior chest X-ray-1
Time frame: within 24 hours of hospitalization
All patients' first PA X-rays taken on the first day of hospitalization will be evaluated by the investigator.
Posteroanterior chest X-ray-2
Time frame: up to 24 hours
All patients' last PA X-rays taken on the day of dischargewill be evaluated by the investigator.
Postoperative pulmonary complication
Time frame: Before discharge (up to 14 days)
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.
3 secondary outcomes
Length of stay in mechanical ventilation
Time frame: up to 24 hours
Length of stay in intencive care unit(ICU)
Time frame: Before discharge ICU (up to 1 day)
Length of hospitalization
Time frame: Before discharge (up to 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 39856565Oner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice ÖNER CENGİZ, PhD. study director
Ankara University
Zeynep ULUŞAN ÖZKAN, MD principal investigator
university of health sciences ankara education and research hospital
Eylem GANİ, Nurse principal investigator
university of health sciences ankara education and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep breathing exercises with a incentive spirometer in people with Breathing Exercises, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate1 (time frame: within 24 hours of hospitalization). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.