NCT07612033

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Position managementActive Cycle of Breathing Techniques ACBTPostoperative pulmonary complications (PPCs)Cardiac surgery (Open heart surgery)Median sternotomyRespiratory rehabilitationAtelectasis preventionNursing-driven intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From the day of surgery until the day of hospital discharge (estimated up to 14 days)

Study Arms (4)

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.

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.

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).

Behavioral: Structured Position Management ProtocolBehavioral: Active Cycle of Breathing Techniques (ACBT)

Interventions

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

Arm 3: Positioning Only GroupArm 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.

Also known as: Arm 2: ACBT Only Group, Arm 4: Combined Group (Positioning + ACBT)
Arm 2: ACBT Only GroupArm 4: Combined Group (Positioning + ACBT)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Heart Hospital, Cardiothoracic Surgery Department

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 34773384BACKGROUND
  • 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.

    PMID: 41254517BACKGROUND
  • 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.

    PMID: 1580723BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sahra Zaki Azer, Professor

    Faculty of nursing-Assuit uiversity

    STUDY CHAIR
  • Amna Abdullah Desoky, Professor

    Faculty of nursing-Assuit uiversity

    STUDY DIRECTOR
  • Mohamed Mahmoud Ahmed, Assistant Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Fathi Abdelhafeez Soliman, MSc, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

December 16, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations