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
Determining the effect of a cough assist device on hemodynamic status and oxygen saturation in mechanically ventilated adult patients with pneumonia admitted to the intensive care unit.
Design
This study is a randomized, open-label clinical trial with parallel groups. Patients are randomly assigned in equal numbers to the control and intervention groups. Statistical analyses will be conducted using SPSS software, version 22. the required sample size was calculated to be a total of 72 patients.
Settings and conduct
This study will be conducted in 2025 on patients over 18 years of age with pneumonia who are under mechanical ventilation and hospitalized in the pulmonary intensive care unit of Firuzgar Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria consisted of ICU patients aged ≥18 years; the presence of pneumonia confirmed by chest X-ray or a positive sputum culture; endotracheal intubation with mechanical ventilation for at least 24 hours.
Exclusion criteria included patients with diaphragmatic hernia; a history of thoracic surgery; a recent history of upper GI surgery patients with pneumothorax and lack of patient cooperation.
Intervention groups
Patients in the control group will receive only the routine hospital physiotherapy, which includes postural drainage, percussion and clapping, vibration, and coughing techniques, In the intervention group, a cough-assist device will be used. This device delivers positive pressure during inspiration to maximally inflate the lungs, followed by a sudden shift from positive to negative pressure.
Main outcome variables
Arterial oxygen saturation percentage; hemodynamic status; respiratory blood-gas status; volume and quality of patients’ pulmonary secretions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251111067960N1
Registration date:2025-11-23, 1404/09/02
Registration timing:registered_while_recruiting
Last update:2025-11-23, 1404/09/02
Update count:0
Registration date
2025-11-23, 1404/09/02
Registrant information
Name
Afrouz Kargaran Dehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 7754
Email address
drkargaran@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Clinical effects of mechanical cough assistance in ventilated ICU patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Iran university of medical science
Street address
Iran University of Medical Sciences, Hemmat Expressway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1593817415
Approval date
2025-07-11, 1404/04/20
Ethics committee reference number
IR.IUMS.FMD.REC.1404.198
Health conditions studied
1
Description of health condition studied
Pneumonia in mechanically ventilated patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
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
3
Description
Tidal volume
Timepoint
One hour before the intervention and daily for five days afterwards
Method of measurement
Ventilator
4
Description
Dynamic compliance
Timepoint
One hour before the intervention and daily for five days afterwards
Method of measurement
Ventilator
5
Description
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
6
Description
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
7
Description
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
8
Description
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
9
Description
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
10
Description
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
11
Description
Successfully extubating
Timepoint
Since the start of study until 48 hours after extubation
Method of measurement
Recording patient count
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Afrouz Kargaran Dehkordi
Street address
Beh afarin St. vali asr Sq
City
Tehran
Province
Tehran
Postal code
1593817415
Phone
+98 38 3333 7754
Email
drkargaran@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Hemmat Expressway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
safa.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afrouz Kargaran Dehkordi
Position
fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.21 yaas complex ali valadi St. beh afarin St. vali asr Sq.
City
tehran
Province
Tehran
Postal code
1593817415
Phone
+98 38 3333 7754
Email
drkargaran@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afrouz kargaran Dehkordi
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 21 Yaas complex, Ali Valadi St. Beh Afarin St. Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593817415
Phone
+98 38 3333 7754
Email
drkargaran@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afrouz kargaran Dehkordi
Position
fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.21 Yaas complex. Ali Valadi St. Beh Afarin St. Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593817415
Phone
00983933337754
Email
drkargaran@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data are potentially shareable once the individuals have been fully de-identified.
When the data will become available and for how long
Access begins 3 months after publication
To whom data/document is available
All investigators employed in academic and scientific institutions within the healthcare system.
Under which criteria data/document could be used
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.”
From where data/document is obtainable
Firoozgar Hospital, Tehran
Iran university of medical science
What processes are involved for a request to access data/document
Submitting a request to the Vice-Chancellor for Research and Technology of Iran University of Medical Sciences to obtain access to the data.