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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mahmoud Fathi Abdelhafeez Soliman, MSc, PhD Candidate
- 電話番号：+201006579808
- メール：mahmoud808@aun.edu.eg
研究場所
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Asyut Governorate
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Asyut、Asyut Governorate、エジプト、71515
- Assiut University Heart Hospital, Cardiothoracic Surgery Department
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コンタクト：
- Mahmoud Soliman
- 電話番号：01006579808
- メール：mahmoud808@aun.edu.eg
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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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|
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実験的：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.
|
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.
他の名前：
|
|
実験的：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
|
|
実験的：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.
他の名前：
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence and Severity of Postoperative Pulmonary Complications (PPCs)
時間枠：Daily from Postoperative Day 1 (POD 1) up to Postoperative Day 7 (POD 7) or until hospital discharge, whichever occurs first.
|
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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of Hospital Stay
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Sahra Zaki Azer, Professor、Faculty of nursing-Assuit uiversity
- スタディディレクター：Amna Abdullah Desoky, Professor、Faculty of nursing-Assuit uiversity
- スタディディレクター：Mohamed Mahmoud Ahmed, Assistant Professor、Assiut University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 1120251456
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IPD プランの説明
医薬品およびデバイス情報、研究文書
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