Cardiopulmonary Rehabilitation In Heart Valve Surgery
NCT Number: NCT06493123
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Valve Diseases
Interventions: OTHER: Conventional Cardiopulmonary Rehabilitation|OTHER: Bottle P.E.P. (Pozitive Expiratory Pressure)|OTHER: Early Mobilization
Sponsor: Istanbul Saglik Bilimleri University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-29
Completion Date: 2025-01-29
Locations: Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital, Istanbul, Uskudar, 34668, Turkey

Summary:
The aim of this study was to investigate the effects of postoperative early mobilization and Bottle-P.E.P. application on respiratory parameters and functional capacity in patients undergoing heart valve surgery.

Primary Outcome Measures: European System for Cardiac Operative Risk Evaluation (EuroSCORE):, Mortality Risk Assessment is a risk scoring system used to predict mortality in the preoperative period in cardiac surgery.

EuroSCORE: 0-3 points will be considered Low risk, 4-6 points will be considered Medium risk, 7 and above will be considered High risk., Preoperative period|New York Heart Association (NHYA) Functional Class Assessment:, The severity of symptoms in heart failure can be graded according to the amount of exertion that produces the symptom. It is a classification that grades heart failure into four separate classes in order to evaluate the effects of heart failure on functional capacity.

NYHA Classification - The Stages of Heart Failure:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., Preoperative period|Respiratory function test:, Patients will be evaluated with spirometric measurements according to the American Thoracic Society and European Respiratory Society guidelines. Absolute values of FEV1, and forced vital capacity (FVC) were obtained, and their percent of the predicted values (% pred) were calculated .

An obstructive spirometric pattern was defined as FEV1/FVC \< 70%, and a restrictive spirometric pattern was defined as both FEV1/FVC ≥ 70% and FVC \< 80% pred., Preoperative 1st and 7th days|Baseline transthoracic echocardiography:, Diastolic dysfunction and reduced ejection fraction (≤ 54% in females, and ≤ 52% in males) were defined according to the current guidelines.

Interventricular septal thickness (IVSd), posterior wall thickness (PWd), and LV dimension (LVEDD) were all measured at end-diastole.

The LV mass (LVM) was calculated according to the Deveraux formula using these measurements: LVM (g) = 0.80 × {1.04\[(IVSd + LVEDD + PWd)3-(LVEDD)3\]} + 0.6. LVM-index (LVMI) was calculated by dividing LVM by body surface area (BSA). BSA was calculated with the Mosteller formula.

LV hypertrophy (LVH) was defined as LVMI ≥ 102 g/m2 for males and ≥ 88 g/m2 for females, Preoperative 1st and 7th days|NT-ProBNP measurement:, NT-proBNP levels are useful in diagnosing heart failure and monitoring treatment effectiveness. High NT-proBNP levels may increase the severity or risk of heart failure.

Normal values; For NT-proBNP, \<125 pg/ml (\<450 pg/ml over 75 years of age) is acceptable., Preoperative 1st and 7th days|Functional capacity assessment:, The 6 Minute Walk Test (6MWT) will be performed according to the recommendations of the American Thoracic Society. Patients will be instructed to walk the longest distance at the fastest speed possible for a period of 6 minutes. The length of the walking track will be 30 m. The physical therapist will provide standard stimulation every minute. If necessary, the patient will be allowed to rest during the test and this time will be included in the total test time. The test will be performed twice with 1-hour intervals between tests. The best distance will be recorded. The minimum clinically significant difference considered will be 25 m., Preoperative 1st and 7th days|The Borg Category-Ratio scale (Borg CR-10) and The Modified Borg Dyspnea Scale (MBS):, The Borg CR10 is a general intensity scale with specific bases for measuring effort and fatigue. Participants will be asked to mark their perceived level of fatigue on a vertical scale from 0 to 10 before and after the six-minute walk test.

The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 numerical score used to measure self-reported dyspnea during submaximal exercise. Participants will be asked to circle or mark the number that best describes their level of dyspnea before and after the six-minute walk test., Preoperative 1st and 7th days|Functional Independence Measurement (FIM):, The level of independence in daily living activities is an assessment tool used to evaluate the patient's functional status throughout the rehabilitation process.

FIM is divided into two domains: Motor and Cognitive. It consists of a total of 18 items, 13 items in the motor domain and 5 items in the cognitive domain. Each item in the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to accomplish each item. 1 = activities are done completely dependently, 7 = activities are done independently by the individual. A final total score is created and individuals' scores range from 18-126, where a score of 18 represents the individual is completely dependent and 126 represents complete independence., Preoperative 1st and 7th days]|Visual Analog Scale - Pain Assessment:, Visual Analog Scale (VAS) was used to assess the pain severity of the patients. Chest pain before the operation and incision site pain in addition to chest pain after the operation will be questioned.

The minimum clinical significance level for the scale (Minimal clinically important differences) will be taken as an MCID value of 3. VAS is a subjective pain assessment scale that determines pain levels by having patients mark the point where they feel their pain on a 10-centimeter horizontal line.

Marked on the scale are 0 - no pain, 10 - unbearable pain. The marked point will be measured with a ruler and recorded., Preoperative 1st and 7th days
Secondary Outcome Measures: RASS (Richmond Agitation and Sedation Scale):, It will be used for Agitation, Anxiety and Sedation Assessment. RASS score is a 10-point scale with points between +4 and -5. +1 and +4 points indicate the presence and severity of anxiety and agitation, 0 points indicate alertness and calm, -1 and -5 points indicate sedation level. If RASS is ≤ -3 or \>+2: A consultation will be held with the specialist physician about starting rehabilitation, and after the patient's sedation and analgesic medical treatment is arranged, the decision to start rehabilitation will be made with the approval of the patient-physician.

RASS ≤ -2 or \<+1 rehabilitation will begin. An evaluation will be performed before treatment in the intensive care unit on the first postoperative day., Postoperative 1st day in intensive care unit|Evaluation of hemodynamic and respiratory parameters:, 1. Heart Rate

   * Unit of Measure: Beats per minute (bpm)
   * Normal Range: 60-120 bpm
2. Systolic Blood Pressure

   * Unit of Measure: Millimeters of mercury (mmHg)
   * Normal Range: \>90 and \<200 mmHg
3. Respiratory Rate

   * Unit of Measure: Breaths per minute (b/min)
   * Normal Range: \<35 b/min
4. Inspired Fractional Oxygen Amount (FiO2)

   * Unit of Measure: Percentage (%)
   * Calculation: FiO2 (%) = 21 + (L/min Oxygen x 4)
   * Normal Range: ≤60%
5. Positive End-Expiratory Pressure (PEEP)

   * Unit of Measure: Centimeters of water (cmH2O)
   * Normal Range: ≤10 cmH2O
6. Oxygenation Adequacy

   * Unit of Measure: Percentage (%)
   * Normal Range: SaO2 ≥90%
7. Gas Exchange and Oxygenation Status (PaO2/FiO2 Ratio)

   * Unit of Measure: Millimeters of mercury (mmHg)
   * Normal Range: 300-500 mmHg
   * Abnormal Range: \<300 mmHg indicates abnormal gas exchange, \<200 mmHg indicates severe hypoxemia
8. Vasopressor Use • Unit of Measure: Dosage amount, Postoperative 1st day|Arterial blood gas measurements:, Oxygenation will be calculated by recording the PaO2/FiO2 ratio from arterial blood gas samples taken in the intensive care unit on postoperative day 1, before the mobilization program and 30 minutes after recovery.

Normal PaO2/FiO2 ratio of 300-500 mmHg is considered normal. Values \<1300 mmHg indicate abnormal gas exchange, and \<200 mmHg indicate severe hypoxemia.

FiO2 (%)= 21 + (L/min Oxygen x 4), Postoperative 1st day in intensive care unit|Postoperative complication evaluation:, It will be diagnosed by the clinician if one or more of the following criteria are present:

1. pneumonia-presence of radiological evidence of pulmonary infiltration associated with at least two findings including purulent sputum, elevated body temperature (\&gt;38.0°C) or leukocytosis (⩾25% above preoperative baseline);
2. tracheobronchitis-marked increase in sputum production or presence of purulent sputum in a patient with a normal chest X-ray;
3. atelectasis with clinical implications-radiological evidence of lung atelectasis associated with dyspnea;
4. Hypoxemia and oxygen demand below SpO2 \< 85%;
5. Acute respiratory failure-acute lack of gas exchange requiring invasive or noninvasive mechanical ventilation.
6. Permanent stroke
7. Postcardial tamponade
8. Postoperative delirium, Postoperative 1st and 7th days|Length of hospital stay:, Hospital stay (evaluated up to 7 days), Duration of hospital stay