Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2020-12-12
2021-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Closed Aspiration on Hemodynamic Changes and Pain
NCT06143865
The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters
NCT05750524
The Affecting Factors on Airway Temperature and Moisture
NCT04204746
The Effect of Intubation Without Muscle Relaxation on Post Operative Recovery Conditions: Double Blind Randomized Controlled Study
NCT03824470
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
NCT03862391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pain on Endotracheal Suction
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.
Suction
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Suction
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cumhuriyet University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zuhal Gülsoy
Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cumhuriyet University
Sivas, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Zuhal Gülsoy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.