Lobotomy Syndrome
Conditions
Keywords
Acapella device Flutter device Post-lobectomy patients Secretion clearance Dyspnea Arterial blood gases Lung function Chest physiotherapy
Brief summary
Lobectomy patients frequently experience postoperative respiratory complications such as secretion retention, dyspnea, impaired gas exchange, and reduced lung function, which can delay recovery. Oscillatory Positive Expiratory Pressure (OPEP) devices such as Acapella and Flutter are commonly used to improve airway clearance and pulmonary function. This study aims to compare the effects of Acapella and Flutter devices on secretion clearance, dyspnea, arterial blood gases, and lung function in post-lobectomy patients.
Detailed description
Lobectomy is a common surgical procedure performed for the treatment of various pulmonary conditions, particularly lung cancer. Although effective, the procedure is often associated with postoperative respiratory complications including mucus retention, reduced lung volumes, impaired ventilation, and difficulty breathing. These complications can prolong hospital stay, increase the risk of infection, and negatively affect functional recovery. Respiratory physiotherapy plays an important role in preventing and managing these complications. Oscillatory Positive Expiratory Pressure (OPEP) devices are widely used to facilitate airway clearance by generating positive expiratory pressure and oscillations during exhalation. These mechanisms help mobilize retained secretions, improve ventilation, enhance lung expansion, and support overall pulmonary recovery. Acapella and Flutter are two commonly used OPEP devices. Both have demonstrated beneficial effects on mucus clearance, pulmonary function, oxygenation, and symptom management in patients with respiratory disorders and postoperative conditions. Previous studies have reported improvements in respiratory parameters and functional outcomes following the use of these devices as part of pulmonary rehabilitation programs. Despite the growing use of OPEP devices in clinical practice, evidence directly comparing Acapella and Flutter in patients recovering from lobectomy remains limited. Most available studies have focused on chronic respiratory diseases or evaluated these devices independently rather than comparing their effectiveness in a postoperative population. Furthermore, limited information is available regarding their relative effects on secretion clearance, dyspnea, arterial blood gases, and lung function after lobectomy. Therefore, this study is designed to address this gap and provide evidence regarding the comparative effectiveness of Acapella and Flutter devices in postoperative pulmonary rehabilitation.
Interventions
DEVICEAcapella Device Therapy (Experimental Arm 1):
1\. Acapella Device Therapy (Experimental Arm 1): Participants will use the Acapella device, which provides a combination of oscillating positive expiratory pressure (OPEP) and airway vibration to facilitate mucus clearance. Patients will be trained in proper technique and will perform the intervention twice daily for 7 days. Each session will follow a standardized protocol to ensure consistency in breathing pattern and device usage.
DEVICEFlutter Device Therapy (Experimental Arm 2):
Flutter Device Therapy (Experimental Arm 2): Participants will use the Flutter device, which generates oscillating positive expiratory pressure during exhalation to mobilize bronchial secretions. Patients will be instructed in correct positioning and breathing technique. The intervention will also be administered twice daily for 7 days using a standardized protocol.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will follow a parallel-group, randomized controlled trial design with two intervention arms. Eligible post-lobectomy patients will be randomly allocated into: Group A: Acapella device therapy Group B: Flutter device therapy Both groups will receive the assigned intervention using a standardized protocol (2 sessions per day for 7 days). The interventions will be delivered in a parallel manner, meaning each participant will remain in their originally assigned group throughout the study without crossover. Outcome measures, including dyspnea (Modified Borg Scale), lung function (spirometry), arterial blood gases, and secretion clearance, will be assessed at baseline, day 3, and day 5 to evaluate within-group changes over time and between-group differences in treatment effects. The study is single-blinded, where the outcome assessor will be blinded to group allocation to minimize assessment bias.
Eligibility
Sex/Gender
ALL
Age
35 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 35 to 54 years * Both male and female patients * Patients who have undergone lobectomy surgery * Hemodynamically stable patients * Patients with adequate respiratory function (able to maintain oxygenation) * Patients 48 hours post-surgery * Patients who provide written informed consent to participate in the study
Exclusion criteria
* Hemodynamically unstable patients * Patients within less than 48 hours post-surgery * Presence of pneumothorax or air leak complications * Patients with recent major trauma or additional surgery * Patients with unstable cardiac conditions * Patients with massive hemoptysis * Patients unable to cooperate or perform breathing exercises with devices * Any contraindication to airway clearance techniques as judged by the clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dyspnea Score | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Change in perceived breathlessness measured using the Modified Borg Dyspnea Scale (0-10, higher scores indicate greater dyspnea). |
| Forced Expiratory Volume in One Second (FEV₁) | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Forced Expiratory Volume in one second (FEV₁) measured using spirometry and reported in liters (L). |
| Forced Vital Capacity (FVC) | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L). |
| FEV₁/FVC Ratio | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Ratio of Forced Expiratory Volume in one second to Forced Vital Capacity (FEV₁/FVC) measured using spirometry and reported as a percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sputum Volume | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Volume of sputum expectorated over a 24-hour period, reported in milliliters (mL), to assess airway secretion clearance. |
| Partial Pressure of Oxygen (PaO₂) | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Arterial partial pressure of oxygen (PaO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg). |
| Partial Pressure of Carbon Dioxide (PaCO₂) | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Arterial partial pressure of carbon dioxide (PaCO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg). |
| Arterial Blood pH | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Arterial blood pH measured using arterial blood gas analysis. |
| Bicarbonate Concentration (HCO₃-) | Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5 | Arterial bicarbonate (HCO₃-) concentration measured using arterial blood gas analysis and reported in millimoles per liter (mmol/L). |
Countries
Pakistan
Contacts
CONTACTHumera Ayub, MSCPPT
PRINCIPAL_INVESTIGATORTanzeela Nazir, MSCPPT
Riphah International University
Outcome results
None listed