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Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery

Effect of Positioning Combined With Active Cycle of Breathing Techniques on Pulmonary Complications After Cardiac Surgeries

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07612033
Acronym
P-ACBT
Enrollment
124
Registered
2026-05-28
Start date
2026-06-15
Completion date
2027-01-01
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Cardiac Surgery With Sternotomy, Postoperative Pneumonia, Postoperative Pulmonary Complications (PPCs)

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

Brief 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. 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.

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: 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.

Interventions

BEHAVIORALStructured Position Management Protocol

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

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence and Severity of Postoperative Pulmonary Complications (PPCs)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.

Secondary

MeasureTime frameDescription
Length of Hospital StayFrom the day of surgery until the day of hospital discharge (estimated up to 14 days)The total number of days the patient remains hospitalized following cardiac surgery. Lower lengths of stay indicate a faster functional recovery.

Countries

Egypt

Contacts

CONTACTMahmoud Fathi Abdelhafeez Soliman, MSc, PhD Candidate
mahmoud808@aun.edu.eg+201006579808
STUDY_CHAIRSahra Zaki Azer, Professor

Faculty of nursing-Assuit uiversity

STUDY_DIRECTORAmna Abdullah Desoky, Professor

Faculty of nursing-Assuit uiversity

STUDY_DIRECTORMohamed Mahmoud Ahmed, Assistant Professor

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026