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IRCT20251111067960N1 IRCT 2025-11-23 Iran University of Medical Sciences Clinical effects of mechanical cough assistance in ventilated ICU patients Effect of a cough assist device on hemodynamic status and oxygen saturation in mechanically ventilated adult patients with pneumonia adimitted to the pulmonary intensive care unit 2025-11-22 anticipated 90 Complete https://irct.ir/trial/87451 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: patients are randomly and equally assigned to two groups: the control group (recieving routin respiratory physiotherapy) and the intervention group (recieving cough assist therapy). randomization is preformed using computer generated randomization by an individual who is not involved in the study process. N/A Pneumonia in mechanically ventilated patients. Intervention 1: Control Group: Patients in the control group received only the routine hospital physiotherapy, which consisted of postural drainage, percussion, vibration, and coughing. These interventions were performed in five different drainage positions for both lungs:1. Prone position with a pillow placed under the abdomen for drainage of the lower lobes. 2–3. right and left lateral decubitus positions with a pillow under the lateral chest wall for the middle lobes.2. Supine position for drainage of the anterior segment of the upper lobes.3. Semi-sitting position leaning forward for drainage of the posterior segments of the upper lobes.Each lung lobe was positioned in its corresponding drainage posture for approximately 5 minutes. During this time, 20–40 percussions were applied to each thoracic lobe. Following percussion, three vibrations were delivered during expiration. At the end of the physiotherapy session, the patient’s secretions were drained and suctioned. Tracheal stimulation (instilling normal saline into the endotracheal tube followed by suctioning) was also performed at the end of each session.Each chest physiotherapy session lasted 30 minutes and was administered once daily. All procedures were carried out by experienced physiotherapists. Additionally, patients were not allowed to receive gavage feeding or nebulization for at least 2 hours before chest physiotherapy. Intervention 2: Intervention group: In the study group, a cough-assist device was used. This device applies positive pressure during inspiration to maximize lung volume, followed by a rapid shift from positive to negative pressure, thereby simulating the cough mechanism and facilitating more effective secretion clearance. The device used in this study was the Philips T70 Cough Assist (USA).Initially, the percussor mode of the device was applied for 5 minutes using a frequency of 300–400 Hz, a positive pressure of 20–40 cmH₂O, and an airflow intensity ranging from low to maximum to loosen airway secretions. Subsequently, the device’s Auto-Sync mode was used with the following settings: positive pressure 20–40 cmH₂O, negative pressure –20 to –40 cmH₂O, oxygen flow from low to maximum (up to 15 L/min), inspiratory time 1.5 seconds, expiratory time 2.5 seconds, and a pause between inspiration and expiration of 0.3–1 second.In Auto-Sync mode, five inspiratory–expiratory cycles were performed, followed by a 20-second rest, and then the cycles were repeated (3–5 cycles total). This sequence was repeated for 5 minutes. A 1-second pause was provided between each inspiratory–expiratory cycle to allow adequate time for secretion drainage through the endotracheal tube. All patients were positioned in a semi-sitting posture during the mechanical cough-assist procedure. During each mechanical inspiration and expiration, the cough-assist tube was connected to the patient's endotracheal tube.All device parameters within the specified ranges were adjusted based on the patient’s vital signs and comfort, taking into account three factors:1. Hemodynamic status2. Patient tolerance3. The amount of sputum and secretionsThe device was used once daily, and these patients did not receive any physiotherapy interventions. The number of sessions was prescribed by the attending physician and performed by trained physiotherapists or nurses. After each session, auscultation of the lungs and verification of ventilator waveforms were performed to confirm the absence of residual secretions.It should be noted that arterial oxygen saturation and hemodynamic parameters—including **RR, HR**, and ventilator-related parameters such as TV and C_dyn —were recorded, assessed, and compared daily for five days, one hour before and after each treatment session. Additionally, respiratory venous blood gas (VBG) parameters, including PCO₂, HCO₃⁻, and pH, were recorded, evaluated, and compared before the intervention and daily for five days after the intervention. Yes - There is a plan to make this available What will be shared: All data are potentially shareable once the individuals have been fully de-identified. When: Access begins 3 months after publication To whom: All investigators employed in academic and scientific institutions within the healthcare system. Conditions: Access to the data and documentation is permitted solely for research purposes and for use in subsequent studies. All rights of the researchers and contributors involved in this project are fully reserved.” Where to obtain: Firoozgar Hospital, Tehran Iran university of medical science How to obtain: Submitting a request to the Vice-Chancellor for Research and Technology of Iran University of Medical Sciences to obtain access to the data. Comments:
public Afrouz Kargaran Dehkordi
No.21 yaas complex ali valadi St. beh afarin St. vali asr Sq.
tehran Iran (Islamic Republic of) 1593817415 +98 38 3333 7754 drkargaran@yahoo.com Iran University of Medical Sciences scientific Afrouz kargaran Dehkordi
No. 21 Yaas complex, Ali Valadi St. Beh Afarin St. Vali Asr Sq
Tehran Iran (Islamic Republic of) 1593817415 +98 38 3333 7754 drkargaran@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) ICU admitted patiens with at lest 18 years of age Confirmed pneumonia in chest x ray or positive sputum culture Intubated patients who are mechanically ventilated for at least 24 hours Presence of tracheal tube in patient's airway Absence of pneumothorax within a month prior to the study 18 years no limit Both Presence diaphragmatic hernia Patients with a history of thorasic surgery Patients with recent history of upper GI surgery Patients with primary neuromuscular disease Patients with pneumothorax in the presence of a chest tube Lack of patient consent Rehabilitation Rehabilitation Control Group: Patients in the control group received only the routine hospital physiotherapy, which consisted of postural drainage, percussion, vibration, and coughing. These interventions were performed in five different drainage positions for both lungs:1. Prone position with a pillow placed under the abdomen for drainage of the lower lobes. 2–3. right and left lateral decubitus positions with a pillow under the lateral chest wall for the middle lobes.2. Supine position for drainage of the anterior segment of the upper lobes.3. Semi-sitting position leaning forward for drainage of the posterior segments of the upper lobes.Each lung lobe was positioned in its corresponding drainage posture for approximately 5 minutes. During this time, 20–40 percussions were applied to each thoracic lobe. Following percussion, three vibrations were delivered during expiration. At the end of the physiotherapy session, the patient’s secretions were drained and suctioned. Tracheal stimulation (instilling normal saline into the endotracheal tube followed by suctioning) was also performed at the end of each session.Each chest physiotherapy session lasted 30 minutes and was administered once daily. All procedures were carried out by experienced physiotherapists. Additionally, patients were not allowed to receive gavage feeding or nebulization for at least 2 hours before chest physiotherapy. Intervention group: In the study group, a cough-assist device was used. This device applies positive pressure during inspiration to maximize lung volume, followed by a rapid shift from positive to negative pressure, thereby simulating the cough mechanism and facilitating more effective secretion clearance. The device used in this study was the Philips T70 Cough Assist (USA).Initially, the percussor mode of the device was applied for 5 minutes using a frequency of 300–400 Hz, a positive pressure of 20–40 cmH₂O, and an airflow intensity ranging from low to maximum to loosen airway secretions. Subsequently, the device’s Auto-Sync mode was used with the following settings: positive pressure 20–40 cmH₂O, negative pressure –20 to –40 cmH₂O, oxygen flow from low to maximum (up to 15 L/min), inspiratory time 1.5 seconds, expiratory time 2.5 seconds, and a pause between inspiration and expiration of 0.3–1 second.In Auto-Sync mode, five inspiratory–expiratory cycles were performed, followed by a 20-second rest, and then the cycles were repeated (3–5 cycles total). This sequence was repeated for 5 minutes. A 1-second pause was provided between each inspiratory–expiratory cycle to allow adequate time for secretion drainage through the endotracheal tube. All patients were positioned in a semi-sitting posture during the mechanical cough-assist procedure. During each mechanical inspiration and expiration, the cough-assist tube was connected to the patient's endotracheal tube.All device parameters within the specified ranges were adjusted based on the patient’s vital signs and comfort, taking into account three factors:1. Hemodynamic status2. Patient tolerance3. The amount of sputum and secretionsThe device was used once daily, and these patients did not receive any physiotherapy interventions. The number of sessions was prescribed by the attending physician and performed by trained physiotherapists or nurses. After each session, auscultation of the lungs and verification of ventilator waveforms were performed to confirm the absence of residual secretions.It should be noted that arterial oxygen saturation and hemodynamic parameters—including **RR, HR**, and ventilator-related parameters such as TV and C_dyn —were recorded, assessed, and compared daily for five days, one hour before and after each treatment session. Additionally, respiratory venous blood gas (VBG) parameters, including PCO₂, HCO₃⁻, and pH, were recorded, evaluated, and compared before the intervention and daily for five days after the intervention. Arterial oxygen saturation is measured using a pulse oximeter. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Pulse oximeter. Hemodynamic status, including heart rate and respiratory rate, is assessed by the ventilator. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Ventilator. Tidal volume. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Ventilator. Dynamic compliance. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Ventilator. Venous partial pressure of oxygen. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Venous blood gas lab test. Venous partial pressure of carbon dioxide. Timepoint: One hour before the intervention and daily for five days afterwards. Method of measurement: Venous blood gas lab test. Respiratory arterial blood gas status in patients before and after treatment. Timepoint: Before treatment and a day after treatment. Method of measurement: Venous blood gas. The volume and quality of patient's pulmonary secretions are assessed during suctioning. Timepoint: After intervention. Method of measurement: Collection of secretions in a sterile container. The duration of mechanical ventilation and intubation, as well as the length of stay in the intensive care unit, are recorded. Timepoint: Since the start of study. Method of measurement: Recording in patient files. The percentage of patients weaned from the ventilator and the percentage of intubated patients successfully extubated. Timepoint: Since the start of study. Method of measurement: Patients counting. Successfully extubating. Timepoint: Since the start of study until 48 hours after extubation. Method of measurement: Recording patient count. Iran University of Medical Sciences Approved 2025-07-11 Ethics comittee of Iran university of medical science Iran University of Medical Sciences, Hemmat Expressway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)