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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

-

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.

-

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cumhuriyet University

    Sivas

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04634474
Study groupRoleWhat they receive
Pain on Endotracheal SuctionExperimentalBefore 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.

  1. 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)
  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.

  1. First posted18 Nov 2020
  2. Study start12 Dec 2020
  3. Primary completion14 Apr 2021
  4. Study completion14 Apr 2021

Resources

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)
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

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.

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