- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07612033
Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery (P-ACBT)
Effect of Positioning Combined With Active Cycle of Breathing Techniques on Pulmonary Complications After Cardiac Surgeries
The goal of this quasi-experimental clinical trial is to learn if position management combined with the Active Cycle of Breathing Techniques (ACBT) works to reduce postoperative pulmonary complications in adult patients undergoing elective cardiac surgery. It will also evaluate the individual effects of each technique compared to routine care.
The main questions it aims to answer are:
Does the combination of positioning and ACBT significantly lower the incidence and severity of postoperative pulmonary complications (like atelectasis, pneumonia, and respiratory failure) within the first 7 days after surgery? Does the combination of these techniques reduce the length of hospital stay compared to using each technique alone or routine care? Does the application of ACBT alone lower the rate of respiratory infections? Does position management alone improve oxygenation parameters (such as SpO_{2} and PaO_{2})?
Researchers will compare four groups of patients to determine the most effective nursing approach:
Group 1 (Control Group): Participants will receive routine postoperative hospital care only.
Group 2 (ACBT Group): Participants will perform the Active Cycle of Breathing Techniques (breathing control, thoracic expansion, and huffing) three times daily for 10-15 minutes over 5 postoperative days.
Group 3 (Positioning Group): Participants will receive structured position management exclusively, shifting from head elevation (30-45) early after surgery to a semi-recumbent position (approx60) during waking hours, alongside other positions like lateral or forward-leaning as tolerated.
Group 4 (Combined Group): Participants will receive both structured position management and perform the ACBT sessions according to the same schedules.
All participants will undergo daily respiratory assessments using a standardized scoring system for 7 days post-surgery or until hospital discharge.
Przegląd badań
Status
Warunki
Szczegółowy opis
This quasi-experimental, non-equivalent control group study is designed to evaluate the clinical impact of position management, the Active Cycle of Breathing Techniques (ACBT), and their combined application on reducing postoperative pulmonary complications (PPCs) among adult patients undergoing elective cardiac surgery via median sternotomy.
Study Phases and Flow:
1. Preparatory Phase: Official administrative approvals will be secured from the director of the cardiothoracic care unit (CTCU) at Assiut University Heart Hospital. The data collection tools will be validated by a jury panel of five experts in medical-surgical nursing and cardiothoracic surgery.
Internal consistency will be evaluated using Cronbach's Alpha. A pilot study involving 10% of the sample size (13 patients) will be conducted to test feasibility and timing, and these patients will be excluded from the final analysis.
Eligible patients will be approached preoperatively to explain the study's purpose, benefits, and risks, and voluntary written informed consent will be obtained.
Implementation Phase:
Patients meeting the specific eligibility criteria will be enrolled. Preoperatively, baseline demographic attributes, clinical medical history, initial diagnostic studies (e.g., complete blood count, chest X-ray, arterial blood gas markers), and baseline vital signs will be documented. Patients allocated to the intervention arms will receive preoperative training on ACBT maneuvers and orientation regarding the postoperative position protocols.
During and immediately following surgery, operative variables such as extracorporeal circulation time, aortic cross-clamp time, and intraoperative blood transfusions will be extracted from anesthesia and surgical flow sheets. Patients will then be allocated into one of the four study groups. Group Interventions:
- Group 1 (Control Group): Participants receive only the standard, routine postoperative hospital care protocols.
- Group 2 (ACBT Group): Once hemodynamically stable on postoperative day 1 (POD 1), participants perform the active cycle of breathing technique (including breathing control, thoracic expansion exercises, and huffing). Sessions last 10-15 minutes, conducted three times daily across 5 postoperative days.
- Group 3 (Positioning Group): In the early postoperative phase (0-6 hours or until extubation), patients are managed with head elevation at $30-45^{\circ}$ and head turning. Post-extubation/after 6 hours, they are maintained in a semi-recumbent position (approx60) during waking hours and 15-30 during sleep, with forward-leaning, postural drainage, and prone positioning integrated as tolerated.
- Group 4 (Combined Group): Participants receive the structured early head elevation and semi-recumbent positioning, followed by lateral or forward-leaning adjustments. Following extubation and stabilization, they initiate the ACBT sessions on the identical frequency and duration schedule as Group 2. Evaluation Phase:
Continuous daily monitoring of vital signs and clinical progress will be documented from POD 1 to POD 7. The incidence and clinical severity of PPCs will be evaluated daily using the Modified Kroenke Scoring System. Data collection will conclude on POD 7 or upon hospital discharge, whichever occurs first. Statistical analysis will compare the variations across the four groups to identify the most effective nursing practice.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mahmoud Fathi Abdelhafeez Soliman, MSc, PhD Candidate
- Numer telefonu: +201006579808
- E-mail: mahmoud808@aun.edu.eg
Lokalizacje studiów
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Asyut Governorate
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Asyut, Asyut Governorate, Egipt, 71515
- Assiut University Heart Hospital, Cardiothoracic Surgery Department
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Kontakt:
- Mahmoud Soliman
- Numer telefonu: 01006579808
- E-mail: mahmoud808@aun.edu.eg
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult patients (aged from 20 years to 65 years old).
- Undergoing elective cardiac surgery (Coronary Artery bypass Grafting (CABG) or valves surgeries) via median sternotomy.
- Hemodynamically stable postoperatively (no high-dose vasopressor support).
- Fully conscious and capable of following complex verbal instructions.
Exclusion Criteria:
• Patients undergoing emergency cardiac surgery.
- History of chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD), bronchial asthma, or bronchiectasis
- Pre-existing pulmonary complications (e.g., pneumonia, atelectasis, pleural effusion) prior to surgery
- Neuromuscular disorders affecting respiratory muscles
- Severe obesity (e.g., BMI ≥35 kg/m²)
- Cognitive impairment or inability to follow instructions
- Any contraindication to physiotherapy techniques (e.g., unstable sternum, severe pain not controlled)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Arm 1: Control Group
Participants in this group will receive only the standard, routine postoperative hospital care protocols implemented by the cardiothoracic care unit.
No structured positioning maneuvers or Active Cycle of Breathing Techniques (ACBT) will be provided by the researcher
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Eksperymentalny: Arm 2: ACBT Only Group
Participants will perform the Active Cycle of Breathing Techniques (ACBT), which includes breathing control, thoracic expansion exercises, and huffing (forced expiration technique).
Once the patient is hemodynamically stable on postoperative day 1 (POD 1), the technique will be applied in cycles and performed three times daily for 10-15 minutes over 5 postoperative days.
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A structured airway clearance regimen performed independently by the patient following specialized nursing instruction.
The technique integrates breathing control (normal relaxed breathing), thoracic expansion exercises (deep breathing), and the forced expiration technique (huffing) to mobilize peripheral pulmonary secretions.
Once the patient is clinically stable on postoperative day 1 (POD 1), the cycle is performed three times daily for 10-15 minutes, continuing across 5 postoperative days.
Inne nazwy:
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Eksperymentalny: Arm 3: Positioning Only Group
Participants will receive structured position management exclusively.
In the early postoperative phase (0-6 hours or until extubation), patients are managed with head elevation at 30-45 degree and turning the head to one side.
Post-extubation/after 6 hours, patients will be placed in a semi-recumbent position ($\approx60^{\circ}$) during waking hours and 15-30 degree during sleep, with additional advanced positions (forward-leaning, postural drainage, and prone positioning) integrated as tolerated.
|
A systematic nursing-driven positioning protocol designed to utilize gravitational forces to optimize lung volumes and minimize pulmonary secretions.
In the early postoperative phase (0-6 hours or until extubation), patients are managed with head elevation at 30-45 and the head turned to one side.
Post-extubation/after 6 hours, patients are maintained in a semi-recumbent position (approx60during waking hours and 15-30 during sleep.
Additional positions including lateral rotations, forward-leaning, postural drainage, and prone positioning are integrated throughout the stay as clinically tolerated
|
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Eksperymentalny: Arm 4: Combined Group (Positioning + ACBT)
Participants will receive a synchronized combination of both structured position management and the Active Cycle of Breathing Techniques (ACBT).
Positioning protocols (early head elevation and semi-recumbent adjustments) will be followed by advanced position changes (lateral or forward-leaning) as tolerated.
Following extubation and clinical stabilization, ACBT sessions will be initiated on the identical frequency and duration schedule as the ACBT group (three times daily for 10-15 minutes over 5 days).
|
A structured airway clearance regimen performed independently by the patient following specialized nursing instruction.
The technique integrates breathing control (normal relaxed breathing), thoracic expansion exercises (deep breathing), and the forced expiration technique (huffing) to mobilize peripheral pulmonary secretions.
Once the patient is clinically stable on postoperative day 1 (POD 1), the cycle is performed three times daily for 10-15 minutes, continuing across 5 postoperative days.
Inne nazwy:
A systematic nursing-driven positioning protocol designed to utilize gravitational forces to optimize lung volumes and minimize pulmonary secretions.
In the early postoperative phase (0-6 hours or until extubation), patients are managed with head elevation at 30-45 and the head turned to one side.
Post-extubation/after 6 hours, patients are maintained in a semi-recumbent position (approx60during waking hours and 15-30 during sleep.
Additional positions including lateral rotations, forward-leaning, postural drainage, and prone positioning are integrated throughout the stay as clinically tolerated
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence and Severity of Postoperative Pulmonary Complications (PPCs)
Ramy czasowe: Daily from Postoperative Day 1 (POD 1) up to Postoperative Day 7 (POD 7) or until hospital discharge, whichever occurs first.
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Postoperative pulmonary complications (PPCs) will be evaluated using the Modified Kroenke Scoring System. This tool assesses respiratory outcomes on a scale from Grade 0 (no complications) to Grade 5 (death before discharge). * Grades 1 & 2: Indicate mild to moderate complications (e.g., cough, micro-atelectasis, bronchospasm, or hypoxemia). * Grades 3 & 4: Indicate severe to very severe clinically significant complications (e.g., pneumonia, pleural effusion requiring intervention, or mechanical ventilation/re-intubation). Metric: The highest (worst) recorded score within the first 7 postoperative days will be analyzed. A cut-off score of ≥ 3 defines the presence of clinically significant PPCs. |
Daily from Postoperative Day 1 (POD 1) up to Postoperative Day 7 (POD 7) or until hospital discharge, whichever occurs first.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Length of Hospital Stay
Ramy czasowe: From the day of surgery until the day of hospital discharge (estimated up to 14 days)
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The total number of days the patient remains hospitalized following cardiac surgery.
Lower lengths of stay indicate a faster functional recovery.
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From the day of surgery until the day of hospital discharge (estimated up to 14 days)
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Sahra Zaki Azer, Professor, Faculty of nursing-Assuit uiversity
- Dyrektor Studium: Amna Abdullah Desoky, Professor, Faculty of nursing-Assuit uiversity
- Dyrektor Studium: Mohamed Mahmoud Ahmed, Assistant Professor, Assiut University
Publikacje i pomocne linki
Publikacje ogólne
- Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992 May;152(5):967-71.
- Zhong J, Zhang S, Li C, Hu Y, Wei W, Liu L, Wang M, Hong Z, Long H, Rong T, Yang H, Su X. Active cycle of breathing technique may reduce pulmonary complications after esophagectomy: A randomized clinical trial. Thorac Cancer. 2022 Jan;13(1):76-83. doi: 10.1111/1759-7714.14227. Epub 2021 Nov 12.
- Ning G, Sihan C, Daihong J, Zhilong Z, Aihua Z, Liting L, Heling G. Effect of position management combined with active cycle of breathing techniques on reducing postoperative pulmonary complications in lung cancer patients. BMC Cancer. 2025 Nov 18;25(1):1780. doi: 10.1186/s12885-025-15029-4.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1120251456
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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