Postoperative Pulmonary Complications (PPCs)P-ACBTNCT07612033
Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery
A study testing Structured Position Management Protocol and Active Cycle of Breathing Techniques (ACBT) in people with Postoperative Pulmonary Complications (PPCs) and Cardiac Surgery With Sternotomy, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy, Atelectasis
- What is being tested?
- Structured Position Management Protocol and Active Cycle of Breathing Techniques (ACBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 1 Jan 2027
- Phase
- Interventional
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Heart Hospital, Cardiothoracic Surgery Department
Asyut, Asyut Governorate, 71515
Mahmoud Soliman, 01006579808, mahmoud808@aun.edu.eg
About this study
Official title: 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:
Read more
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.
Read the detailed description
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:
- 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.
- Conditions
- Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy, Atelectasis, Postoperative Pneumonia
- Being tested
- Structured Position Management Protocol, Active Cycle of Breathing Techniques (ACBT)
- Keywords
- Position management, Active Cycle of Breathing Techniques ACBT, Postoperative pulmonary complications (PPCs), Cardiac surgery (Open heart surgery), Median sternotomy, Respiratory rehabilitation, Atelectasis prevention, Nursing-driven intervention
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Position Management ProtocolBehavioural
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
Active Cycle of Breathing Techniques (ACBT)Behavioural
Also called Arm 2: ACBT Only Group, Arm 4: Combined Group (Positioning + ACBT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control Group | No intervention | 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 |
| Arm 2: ACBT Only Group | Experimental | 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. Receives: Behavioral: Active Cycle of Breathing Techniques (ACBT) |
| Arm 3: Positioning Only Group | Experimental | 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. Receives: Behavioral: Structured Position Management Protocol |
| Arm 4: Combined Group (Positioning + ACBT) | Experimental | 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). Receives: Behavioral: Structured Position Management Protocol; Behavioral: Active Cycle of Breathing Techniques (ACBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Postoperative Pulmonary Complications (PPCs)
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.
Measured: Daily from Postoperative Day 1 (POD 1) up to Postoperative Day 7 (POD 7) or until hospital discharge, whichever occurs first.
Secondary outcomes (1)
Length of Hospital Stay
The total number of days the patient remains hospitalized following cardiac surgery. Lower lengths of stay indicate a faster functional recovery.
Measured: From the day of surgery until the day of hospital discharge (estimated 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 posted28 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion16 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a quasi-experimental, non-equivalent parallel group design with four distinct arms. A total of 124 patients will be allocated into four parallel groups, with each arm consisting of 31 participants: \* Control Group (Arm 1): Receives standard routine postoperative care protocols only. * ACBT-Only Group (Arm 2): Performs the Active Cycle of Breathing Techniques three times daily for 10-15 minutes across 5 postoperative days, alongside routine care. * Positioning-Only Group (Arm 3): Receives structured position management exclusively (early head elevation followed by semi-recumbent and advanced positional rotations as tolerated), alongside routine care. * Combined Group (Arm 4): Receives the synchronized combination of both structured position management and the Active Cycle of Breathing Techniques, alongside routine care. Participants will maintain their assignment within their designated arm throughout the 7-day postoperative evaluation period or until discharge
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Fathy Abdelhafeez Soliman, Assiut University
- Investigators
- Sahra Zaki Azer, Professor, Study chair, Faculty of nursing-Assuit uiversityAmna Abdullah Desoky, Professor, Study director, Faculty of nursing-Assuit uiversityMohamed Mahmoud Ahmed, Assistant Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612033
- Sponsor's protocol ID
- 1120251456
- Acronym
- P-ACBT
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient confidentiality and ensure strict adherence to the ethical guidelines and informed consent approved by the Institutional Review Board (IRB), the individual participant data collected during this study will not be made publicly available. Only aggregated statistical results will be published in the final dissertation and related journal manuscripts.
Publications
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.
PubMed 34773384Ning 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.
PubMed 41254517Kroenke 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.
PubMed 1580723