Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04634474 |
| Other study ID # |
Zuhal Gülsoy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2020 |
| Est. completion date |
April 14, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Cumhuriyet University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
