Patient InvolvementNCT06277817
The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics
A study testing expiratory rib cage compression and percussion vibration in people with Patient Involvement, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Involvement
- What is being tested?
- expiratory rib cage compression and percussion vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Intubated in the intensive care unit for more than 48 hours
- Followed in synchronized intermittent mechanical ventilation (SIMV) mode
- with arterial catheter
- with hemodynamic stability
- PEEP <10
- Patients with Glasgow Coma Scale >3 were included.
Who cannot join
- Rib fracture, chest trauma
- with pneumothorax
- with hemoptysis
- with increased intracranial pressure
- Having a history of spine surgery
- with chest drainage tube
Show all 12Show fewer
- Those with skin infection and subcutaneous emphysema in the back and chest area
- The mechanical ventilation setting to be changed during the study
- with life-threatening cardiac arrhythmia
- pregnant
- Obese (Body Mass Index >30)
- Patients who had to be aspirated outside of the specified periods during the study were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chest Physiotherapy Techniques Applied Before Aspiration on Vital Signs, Blood Gas Values and Secretion Amount in Patients on Mechanical Ventilation Support
Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.
Read the detailed description
This study was carried out to determine the effect of chest physiotherapy techniques applied before aspiration on the vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.This randomized, controlled and experimental study was conducted between May 2021 and October 2022 in Tunceli State Hospital intensive care units with patients on mechanical ventilation support. The study was completed with a total of 78 patients, including the percussion vibration group (n=26), the expiratory rib cage compression group (n=26), and the control group (n=26). Data were collected with the "Patient Identification Form", "Vital Signs Recording Form", "Blood Gas Values Recording Form" and "Secretion Amount Recording Form". Two aspirations were performed in each of the three groups with an interval of three hours. Three hours after the first aspiration, chest physiotherapy techniques were applied to the two experimental groups, but not to the control group. A second aspiration was then performed. Vital signs and blood gases were measured before and after both aspiration procedures, and the amount of secretion collected during the two aspiration procedures was weighed.In the comparison between groups according to time; Statistically significant changes were found in heart rate during the first aspiration period, and diastolic blood pressure and respiratory rate during the second aspiration period (p<0.05). In the independent comparison between groups; statistically significant difference was found in diastolic blood pressure, respiratory rate and peripheral SpO2 values (p<0.05). In group comparisons; while the averages of secretion weight and amount did not show a significant change in all three groups (p>0.05), it was found that it tended to increase in the percussion-vibration and expiratory rib cage compression groups, while it tended to decrease in the control group.In this study, it was concluded that chest physiotherapy techniques had a beneficial effect on some vital signs in patients on mechanical ventilation support, did not make any difference in other parameters. Further studies are needed to determine the positive effects of these techniques on vital signs, blood gases and secretion.
- Conditions
- Patient Involvement
- Being tested
- expiratory rib cage compression, percussion vibration
- Keywords
- Expiratory rib cage compressio, Chest physiotherapy, Mechanical ventilation, Percussion-Vibration, Intensive care
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expiratory rib cage compressionOther
Expiratory rib cage compression: The hands are placed on the lower third of the rib cage. During expiration, the end and sides of the patients' rib cage are gradually compressed with the hands.At the end of expiration, compression is released from the thorax to allow patients to take a free inspiration. After each compression, the patient is allowed to perform 3 breathing cycles.Expiratory rib cage compression is applied for 5 minutes.
percussion vibrationOther
Percussion :Percussion is performed 3-5 times on each area from a height of approximately 10 cm with the domed hand. . It starts from the right and left lower lobes and goes up.Vibration:The hand is firmly/strongly placed on the application area. The arm and shoulder are stretched and the fingers are gently vibrated or shaken gently. While the patient is exhaling, vibration is performed 3-5 times in each area, starting from the right and left lower lobes.
| Study group | Role | What they receive |
|---|---|---|
| expiratory rib cage compression group | Experimental | Expiratory rib cage compression procedure phase; Three hours after the first aspiration data were obtained, before the second aspiration, expiratory rib cage compression was applied for 5 minutes in the right lateral and left lateral positions, applying to both lungs, with the most affected lung area first. Before and after the procedure, vital signs, blood gas parameters were measured and the amount of secretion collected during the aspiration process was weighed. Receives: Other: expiratory rib cage compression |
| percussion vibration group | Experimental | Percussion, vibration process stage; Three hours after the first aspiration data were obtained, before the second aspiration, percussion and vibration were applied 3-5 times to each area, starting from the right and left lower lobes, in the right lateral and left lateral positions, with the most affected lung area being applied to both lungs first. Vital signs, blood gas parameters were measured before and after the procedure, and the amount of secretion collected during the aspiration process was weighed. Receives: Other: percussion vibration |
| control group | No intervention | Control group phase; In this group, vital signs, blood gases, and secretion amount were recorded at the same time as the experimental groups, without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of percussion vibration on the amount of secretion
Pecussion vibration was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
Measured: about a year
Effect of expiratory rib cage compression on the amount of secretion
Expiratory rib cage compression was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
Measured: about a year
Effect of percussion vibration on blood gas parameters
Percussion vibration was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying percussion vibration
Measured: about a year
Effect of expiratory rib cage compression on blood gas parameters
Expiratory rib cage compression was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying expiratory rib cage compression.
Measured: about a year
Perküsyon vibrasyonun yaşam bulgularına etkisi
Percussion vibration was applied before endotracheal aspiration. Vital signs measurements of systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying percussion vibration.
Measured: about a year
Effect of expiratory rib cage compression on vital signs
Expiratory rib cage compression was applied before endotracheal aspiration. Vital signs measurements such as systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying expiratory rib cage compression.
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start19 May 2021
- Primary completion25 Jun 2021
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient InvolvementStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Parlar Kılıç, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277817
- Sponsor's protocol ID
- 2021/1916
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Olmaz D, Parlar Kilic S. Effects of Pre-Aspiration Chest Physiotherapy Techniques on Vital Signs, Blood Gas Values and Secretions in Mechanically Ventilated Patients. Nurs Crit Care. 2026 Jan;31(1):e70232. doi: 10.1111/nicc.70232.
PubMed 41536156
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chest Physiotherapy Techniques Applied Before Aspiration on Vital Signs, Blood Gas Values and Secretion Amount in Patients on Mechanical Ventilation Support
- ClinicalTrials.gov ID
- NCT06277817
- Acronym / sponsor ID
- 2021/1916
- Conditions
- Patient Involvement
- Keywords
- Expiratory rib cage compressio, Chest physiotherapy, Mechanical ventilation, Percussion-Vibration, Intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.
Detailed description
This study was carried out to determine the effect of chest physiotherapy techniques applied before aspiration on the vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support.This randomized, controlled and experimental study was conducted between May 2021 and October 2022 in Tunceli State Hospital intensive care units with patients on mechanical ventilation support. The study was completed with a total of 78 patients, including the percussion vibration group (n=26), the expiratory rib cage compression group (n=26), and the control group (n=26). Data were collected with the "Patient Identification Form", "Vital Signs Recording Form", "Blood Gas Values Recording Form" and "Secretion Amount Recording Form". Two aspirations were performed in each of the three groups with an interval of three hours. Three hours after the first aspiration, chest physiotherapy techniques were applied to the two experimental groups, but not to the control group. A second aspiration was then performed. Vital signs and blood gases were measured before and after both aspiration procedures, and the amount of secretion collected during the two aspiration procedures was weighed.In the comparison between groups according to time; Statistically significant changes were found in heart rate during the first aspiration period, and diastolic blood pressure and respiratory rate during the second aspiration period (p<0.05). In the independent comparison between groups; statistically significant difference was found in diastolic blood pressure, respiratory rate and peripheral SpO2 values (p<0.05). In group comparisons; while the averages of secretion weight and amount did not show a significant change in all three groups (p>0.05), it was found that it tended to increase in the percussion-vibration and expiratory rib cage compression groups, while it tended to decrease in the control group.In this study, it was concluded that chest physiotherapy techniques had a beneficial effect on some vital signs in patients on mechanical ventilation support, did not make any difference in other parameters. Further studies are needed to determine the positive effects of these techniques on vital signs, blood gases and secretion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized.
| Arm | Type | Receives |
|---|---|---|
| expiratory rib cage compression group | Experimental | Other: expiratory rib cage compressionExpiratory rib cage compression procedure phase; Three hours after the first aspiration data were obtained, before the second aspiration, expiratory rib cage compression was applied for 5 minutes in the right lateral and left lateral positions, applying to both lungs, with the most affected lung area first. Before and after the procedure, vital signs, blood gas parameters were measured and the amount of secretion collected during the aspiration process was weighed. |
| percussion vibration group | Experimental | Other: percussion vibrationPercussion, vibration process stage; Three hours after the first aspiration data were obtained, before the second aspiration, percussion and vibration were applied 3-5 times to each area, starting from the right and left lower lobes, in the right lateral and left lateral positions, with the most affected lung area being applied to both lungs first. Vital signs, blood gas parameters were measured before and after the procedure, and the amount of secretion collected during the aspiration process was weighed. |
| control group | No intervention | –Control group phase; In this group, vital signs, blood gases, and secretion amount were recorded at the same time as the experimental groups, without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older
- Intubated in the intensive care unit for more than 48 hours
- Followed in synchronized intermittent mechanical ventilation (SIMV) mode
- with arterial catheter
- with hemodynamic stability
Key exclusion criteria (12 listed)
- Rib fracture, chest trauma
- with pneumothorax
- with hemoptysis
- with increased intracranial pressure
- Having a history of spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expiratory rib cage compressionExpiratory rib cage compression: The hands are placed on the lower third of the rib cage. During expiration, the end and sides of the patients' rib cage are gradually compressed with the hands.At the end of expiration, compression is released from the thorax to allow patients to take a free inspiration. After each compression, the patient is allowed to perform 3 breathing cycles.Expiratory rib cage compression is applied for 5 minutes. | Other | expiratory rib cage compression group |
| percussion vibrationPercussion :Percussion is performed 3-5 times on each area from a height of approximately 10 cm with the domed hand. . It starts from the right and left lower lobes and goes up.Vibration:The hand is firmly/strongly placed on the application area. The arm and shoulder are stretched and the fingers are gently vibrated or shaken gently. While the patient is exhaling, vibration is performed 3-5 times in each area, starting from the right and left lower lobes. | Other | percussion vibration group |
Primary outcome
The effect of percussion vibration on the amount of secretion
Time frame: about a year
Pecussion vibration was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
Effect of expiratory rib cage compression on the amount of secretion
Time frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration, and the secretion accumulated in the collection container during the aspiration process was weighed and recorded.
Effect of percussion vibration on blood gas parameters
Time frame: about a year
Percussion vibration was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying percussion vibration
Effect of expiratory rib cage compression on blood gas parameters
Time frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration. Measurements of pO2, pH, pCO2, HCO3, SaO2 parameters were recorded 5 minutes before endotracheal aspiration and 25 minutes after applying expiratory rib cage compression.
Perküsyon vibrasyonun yaşam bulgularına etkisi
Time frame: about a year
Percussion vibration was applied before endotracheal aspiration. Vital signs measurements of systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying percussion vibration.
Effect of expiratory rib cage compression on vital signs
Time frame: about a year
Expiratory rib cage compression was applied before endotracheal aspiration. Vital signs measurements such as systolic blood pressure, diastolic blood pressure, respiratory rate, pulse rate, body temperature, and peripheral SpO2 were recorded 5 minutes before endotracheal aspiration and 15 minutes after applying expiratory rib cage compression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 41536156Olmaz D, Parlar Kilic S. Effects of Pre-Aspiration Chest Physiotherapy Techniques on Vital Signs, Blood Gas Values and Secretions in Mechanically Ventilated Patients. Nurs Crit Care. 2026 Jan;31(1):e70232. doi: 10.1111/nicc.70232.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expiratory rib cage compression and percussion vibration in people with Patient Involvement, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of percussion vibration on the amount of secretion (time frame: about a year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.