Endotracheal SuctionNCT04634474
The Effect of Closed System Suction on Pain
A study testing Suction in people with Endotracheal Suction and Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation and mechanical ventilation are life-saving practices in patients with respiratory failure, and aspiration of secretions is often required to maintain airway patency. Although tracheal aspiration is an unavoidable requirement to maintain airway patency, it can bring many undesirable conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Suction, Pain
- What is being tested?
- Suction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 14 Apr 2021
- 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
Inclusion Criteria:Conscious Open communicable having an tracheal tube or tracheostomy Not using pain medication Patients who do not have a neurological disease that will prevent pain will be included in the study.
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Exclusion Criteria:Unconscious, communicated but unable to express their pain numerically Using pain medication Patients with neurological diseases that prevent them from feeling pain will not be included in the study.
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Trial locations and contacts
1 site in 1 country.
About this study
Endotracheal intubation and mechanical ventilation are life-saving practices in patients with respiratory failure, and aspiration of secretions is often required to maintain airway patency. Although tracheal aspiration is an unavoidable requirement to maintain airway patency, it can bring many undesirable conditions. In the presence of complications, the duration of hospital stay is also prolonged. In the literature, endotracheal aspiration is defined as a painful and uncomfortable method for patients. However, pain is an undesirable sensation that cannot be adapted. The most reliable source for pain assessment is the patient himself. However, verbal communication with patients in the ICU is quite difficult due to reasons such as the presence of endotracheal tube and tracheostomy, confusion, mechanical ventilation, and sedative drug use. Therefore, intensive care patients may not be able to express their pain verbally. In this case, patient behavior becomes important in pain assessment. Scales were developed for pain assessment of patients who could not express their pain. The "Behavioral Pain Scale" (DAS) was developed by Payen et al. For this purpose and made available to intensive care patients.
Patients who meet the inclusion criteria and agree to participate in the study when aspirating is required (Seeing pulmonary secretions in the endotracheal tube, tachypnea, tachycardia, hypertension, worsening of oxygen saturation and / or arterial blood gas, sawtooth pattern in the flow volume loop of the ventilator monitor and / or trachea Hearing of coarse breathing sounds, Ppeak inspiratory pressure increase in mechanical ventilator in volume-controlled mode, or tidal volume decrease in pressure-controlled mode, etc.) by a volunteer nurse, whether there is pain before, during and after aspiration, the severity and localization of the pain will be recorded by VAS and VAS. . The patient will be aspirated with the same aspiration technique in all patients by using a closed system aspiration catheter by the other volunteer nurse. Aspiration procedure will be applied to each patient according to the American association for respiratory care (AARC) aspiration guideline. The nurse evaluating the pain will record whether the patients have pain with DAS and VAS, the severity and localization of the pain
Read the detailed description
Endotracheal intubation and mechanical ventilation are life-saving practices in patients with respiratory failure, and aspiration of secretions is often required to maintain airway patency. Although tracheal aspiration is an unavoidable requirement to maintain airway patency, it can bring many undesirable conditions. In the presence of complications, the duration of hospital stay is also prolonged. In the literature, endotracheal aspiration is defined as a painful and uncomfortable method for patients. However, pain is an undesirable sensation that cannot be adapted.
It is thought that performing aspiration in accordance with the AARC guideline and listening to music during the procedure reduce the pain in edotracheal aspiration. The most reliable source for pain assessment is the patient himself. However, verbal communication with patients in the ICU is quite difficult due to reasons such as the presence of endotracheal tube and tracheostomy, confusion, mechanical ventilation, and sedative drug use. Therefore, intensive care patients may not be able to express their pain verbally. In this case, patient behavior becomes important in pain assessment. Scales were developed for pain assessment of patients who could not express their pain. The "Behavioral Pain Scale" (DAS) was developed by Payen et al. For this purpose and made available to intensive care patients. DAS consists of three parts, including facial expression, upper extremity movements, and compliance with mechanical ventilation, and a total of 12 items. Each section is given a score between 1 and 4. The lowest pain score obtained from the scale is 3 and the highest pain score is 12. (Appendix 1) Patients with an unconscious communication can be established with a sign or writing method instead of verbal communication with patients with tracheostomy or tracheal tube. These patients can describe their pain without words. Visual pain scales can be used for this purpose. Visual Pain Scale (VAS) is one of these scales. VAS was first used in the 1970s. The scale was defined by Selby et al. To evaluate the quality of life in patients with cancer in the 1980s. VAS has been used in many studies evaluating different parameters after the 1990s and has recently been used in the measurement of special conditions such as pain. The test has proven itself for a long time and is a accepted test in the world literature. Safe, easy to apply Is DAS an accurate pain descriptor for every application in intensive care unit?;. This question guides the study. This study was planned with the thought that the result may be misleading in applications such as eye care and aspiration that will trigger reflex movements in intensive care.
6-Research protocol, materials and methods: METHOD In this study, when alpha 0.05, = 0.10, 1-B 0.90 was taken, 32 patients were included in the study and the power of the test was found to be P = 0.9657.
Time of Research: Research 01.07. It will be applied in the Anesthesia and Reanimation Intensive Care Unit (EIB) of a university hospital between 2020 - 31.12.2020.
The Type and Purpose of the Study: This study was planned as a prospective observational study in order to examine whether conscious patients connected to mechanical ventilator in the Anesthesia Intensive Care Unit experience pain during the closed system aspiration procedure, and if pain is experienced, whether NAC is reliable in evaluating the pain occurring in endotracheal aspiration.
The Population and Sample of the Study: The population of the study was the sample of all patients who were treated in the Anesthesia and Reanimation Intensive Care unit of a university hospital between the research dates, and the patients who were connected to the ventilator who agreed to participate in the study and underwent endotracheal aspiration.
Research Application Patients who meet the inclusion criteria and agree to participate in the study when aspirating is required (Seeing pulmonary secretions in the endotracheal tube, tachypnea, tachycardia, hypertension, worsening of oxygen saturation and / or arterial blood gas, sawtooth pattern in the flow volume loop of the ventilator monitor and / or trachea Hearing of coarse breathing sounds, Ppeak inspiratory pressure increase in mechanical ventilator in volume-controlled mode, or tidal volume decrease in pressure-controlled mode, etc.) by a volunteer nurse, whether there is pain before, during and after aspiration, the severity and localization of the pain will be recorded by VAS and VAS. . The patient will be aspirated with the same aspiration technique in all patients by using a closed system aspiration catheter by the other volunteer nurse. Aspiration procedure will be applied to each patient according to the American association for respiratory care (AARC) aspiration guideline. The nurse evaluating the pain will record whether the patients have pain with DAS and VAS, the severity and localization of the pain.
Evaluation of the Data: The data obtained from the study are SPSS v.22 (Statistical Package for Social Sciences) package program will be used. When parametric test assumptions are fulfilled, repeated measures variance analysis will be used in the analysis of more than two measurements from a group, and Friedman test will be used when parametric test assumptions are not fulfilled. The level of error will be considered as 0.05.
- Conditions
- Endotracheal Suction, Pain
- Being tested
- Suction
- Keywords
- endotracheal suction, ,, pain,, behavioral pain scale
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuctionBehavioural
Is DAS an accurate pain descriptor for every application in intensive care unit?;. This question guides the study. This study was planned with the thought that the result may be misleading in applications such as eye care and aspiration that will trigger reflex movements in intensive care. In addition, creating new evidence on whether endotracheal suction is a painful application is the basis of the application.
| Study group | Role | What they receive |
|---|---|---|
| Pain on Endotracheal Suction | Experimental | Before and after endotracheal aspiration, the pain of the patient will be evaluated according to the DAS and VAS scale. VAS scores will be compared with DAÖ scores. Aspiration process will be applied to all patients by the same nurse. According to the DAQ, the pain will be assessed by a volunteer nurse who is not a researcher. Receives: Behavioral: Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS Scor
Whether patients feel pain before and after endotracheal aspiration is evaluated by looking at the patient's movements according to the scale developed by Payen. 3 points express no pain, 12 points express unbearable pain
Measured: 30 days
Secondary outcomes (1)
VAS scor
Whether the patients feel pain before and after the endotracheal aspiration procedure, the patient expresses 0 no pain, 10 unbearable pain.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start12 Dec 2020
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
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 Endotracheal SuctionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhal Gülsoy, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634474
- Sponsor's protocol ID
- Zuhal Gülsoy
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulsoy Z, Ozdemir Kol I. The Effect of Endotracheal Suctioning on Pain in Conscious Adult Patients in Intensive Care Unit. Dimens Crit Care Nurs. 2024 Mar-Apr 01;43(2):72-79. doi: 10.1097/DCC.0000000000000624.
PubMed 38271311
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Closed System Suction on Pain
- ClinicalTrials.gov ID
- NCT04634474
- Acronym / sponsor ID
- Zuhal Gülsoy
- Conditions
- Endotracheal Suction, Pain
- Keywords
- endotracheal suction, ,, pain,, behavioral pain scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 18 Nov 2020 (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.
Endotracheal intubation and mechanical ventilation are life-saving practices in patients with respiratory failure, and aspiration of secretions is often required to maintain airway patency. Although tracheal aspiration is an unavoidable requirement to maintain airway patency, it can bring many undesirable conditions. In the presence of complications, the duration of hospital stay is also prolonged. In the literature, endotracheal aspiration is defined as a painful and uncomfortable method for patients. However, pain is an undesirable sensation that cannot be adapted. The most reliable source for pain assessment is the patient himself. However, verbal communication with patients in the ICU is quite difficult due to reasons such as the presence of endotracheal tube and tracheostomy, confusion, mechanical ventilation, and sedative drug use. Therefore, intensive care patients may not be able to express their pain verbally. In this case, patient behavior becomes important in pain assessment. Scales were developed for pain assessment of patients who could not express their pain. The "Behavioral Pain Scale" (DAS) was developed by Payen et al. For this purpose and made available to intensive care patients.
Patients who meet the inclusion criteria and agree to participate in the study when aspirating is required (Seeing pulmonary secretions in the endotracheal tube, tachypnea, tachycardia, hypertension, worsening of oxygen saturation and / or arterial blood gas, sawtooth pattern in the flow volume loop of the ventilator monitor and / or trachea Hearing of coarse breathing sounds, Ppeak inspiratory pressure increase in mechanical ventilator in volume-controlled mode, or tidal volume decrease in pressure-controlled mode, etc.) by a volunteer nurse, whether there is pain before, during and after aspiration, the severity and localization of the pain will be recorded by VAS and VAS. . The patient will be aspirated with the same aspiration technique in all patients by using a closed system aspiration catheter by the other volunteer nurse. Aspiration procedure will be applied to each patient according to the American association for respiratory care (AARC) aspiration guideline. The nurse evaluating the pain will record whether the patients have pain with DAS and VAS, the severity and localization of the pain
Detailed description
Endotracheal intubation and mechanical ventilation are life-saving practices in patients with respiratory failure, and aspiration of secretions is often required to maintain airway patency. Although tracheal aspiration is an unavoidable requirement to maintain airway patency, it can bring many undesirable conditions. In the presence of complications, the duration of hospital stay is also prolonged. In the literature, endotracheal aspiration is defined as a painful and uncomfortable method for patients. However, pain is an undesirable sensation that cannot be adapted.
It is thought that performing aspiration in accordance with the AARC guideline and listening to music during the procedure reduce the pain in edotracheal aspiration. The most reliable source for pain assessment is the patient himself. However, verbal communication with patients in the ICU is quite difficult due to reasons such as the presence of endotracheal tube and tracheostomy, confusion, mechanical ventilation, and sedative drug use. Therefore, intensive care patients may not be able to express their pain verbally. In this case, patient behavior becomes important in pain assessment. Scales were developed for pain assessment of patients who could not express their pain. The "Behavioral Pain Scale" (DAS) was developed by Payen et al. For this purpose and made available to intensive care patients. DAS consists of three parts, including facial expression, upper extremity movements, and compliance with mechanical ventilation, and a total of 12 items. Each section is given a score between 1 and 4. The lowest pain score obtained from the scale is 3 and the highest pain score is 12. (Appendix 1) Patients with an unconscious communication can be established with a sign or writing method instead of verbal communication with patients with tracheostomy or tracheal tube. These patients can describe their pain without words. Visual pain scales can be used for this purpose. Visual Pain Scale (VAS) is one of these scales. VAS was first used in the 1970s. The scale was defined by Selby et al. To evaluate the quality of life in patients with cancer in the 1980s. VAS has been used in many studies evaluating different parameters after the 1990s and has recently been used in the measurement of special conditions such as pain. The test has proven itself for a long time and is a accepted test in the world literature. Safe, easy to apply Is DAS an accurate pain descriptor for every application in intensive care unit?;. This question guides the study. This study was planned with the thought that the result may be misleading in applications such as eye care and aspiration that will trigger reflex movements in intensive care.
6-Research protocol, materials and methods: METHOD In this study, when alpha 0.05, = 0.10, 1-B 0.90 was taken, 32 patients were included in the study and the power of the test was found to be P = 0.9657.
Time of Research: Research 01.07. It will be applied in the Anesthesia and Reanimation Intensive Care Unit (EIB) of a university hospital between 2020 - 31.12.2020.
The Type and Purpose of the Study: This study was planned as a prospective observational study in order to examine whether conscious patients connected to mechanical ventilator in the Anesthesia Intensive Care Unit experience pain during the closed system aspiration procedure, and if pain is experienced, whether NAC is reliable in evaluating the pain occurring in endotracheal aspiration.
The Population and Sample of the Study: The population of the study was the sample of all patients who were treated in the Anesthesia and Reanimation Intensive Care unit of a university hospital between the research dates, and the patients who were connected to the ventilator who agreed to participate in the study and underwent endotracheal aspiration.
Research Application Patients who meet the inclusion criteria and agree to participate in the study when aspirating is required (Seeing pulmonary secretions in the endotracheal tube, tachypnea, tachycardia, hypertension, worsening of oxygen saturation and / or arterial blood gas, sawtooth pattern in the flow volume loop of the ventilator monitor and / or trachea Hearing of coarse breathing sounds, Ppeak inspiratory pressure increase in mechanical ventilator in volume-controlled mode, or tidal volume decrease in pressure-controlled mode, etc.) by a volunteer nurse, whether there is pain before, during and after aspiration, the severity and localization of the pain will be recorded by VAS and VAS. . The patient will be aspirated with the same aspiration technique in all patients by using a closed system aspiration catheter by the other volunteer nurse. Aspiration procedure will be applied to each patient according to the American association for respiratory care (AARC) aspiration guideline. The nurse evaluating the pain will record whether the patients have pain with DAS and VAS, the severity and localization of the pain.
Evaluation of the Data: The data obtained from the study are SPSS v.22 (Statistical Package for Social Sciences) package program will be used. When parametric test assumptions are fulfilled, repeated measures variance analysis will be used in the analysis of more than two measurements from a group, and Friedman test will be used when parametric test assumptions are not fulfilled. The level of error will be considered as 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain on Endotracheal Suction | Experimental | Behavioral: SuctionBefore and after endotracheal aspiration, the pain of the patient will be evaluated according to the DAS and VAS scale. VAS scores will be compared with DAÖ scores. Aspiration process will be applied to all patients by the same nurse. According to the DAQ, the pain will be assessed by a volunteer nurse who is not a researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SuctionIs DAS an accurate pain descriptor for every application in intensive care unit?;. This question guides the study. This study was planned with the thought that the result may be misleading in applications such as eye care and aspiration that will trigger reflex movements in intensive care. In addition, creating new evidence on whether endotracheal suction is a painful application is the basis of the application. | Behavioural | Pain on Endotracheal Suction |
Primary outcome
DAS Scor
Time frame: 30 days
Whether patients feel pain before and after endotracheal aspiration is evaluated by looking at the patient's movements according to the scale developed by Payen. 3 points express no pain, 12 points express unbearable pain
1 secondary outcome
VAS scor
Time frame: 90 days
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 19 Apr 2021.
- Derived from this study: PubMed 38271311Gulsoy Z, Ozdemir Kol I. The Effect of Endotracheal Suctioning on Pain in Conscious Adult Patients in Intensive Care Unit. Dimens Crit Care Nurs. 2024 Mar-Apr 01;43(2):72-79. doi: 10.1097/DCC.0000000000000624.
- Individual participant dataSharing planned: No
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Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
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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 Suction in people with Endotracheal Suction and Pain, run by Cumhuriyet 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?
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 19 Apr 2021. 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?
DAS Scor (time frame: 30 days). 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 NCT04634474, 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 19 Apr 2021.