NCT04634474

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

December 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

November 12, 2020

Last Update Submit

April 15, 2021

Conditions

Keywords

endotracheal suction, ,pain,behavioral pain scale

Outcome Measures

Primary Outcomes (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

    30 days

Secondary Outcomes (1)

  • VAS scor

    90 days

Study Arms (1)

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.

Behavioral: Suction

Interventions

SuctionBEHAVIORAL

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.

Pain on Endotracheal Suction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain

Interventions

Suction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

December 12, 2020

Primary Completion

April 14, 2021

Study Completion

April 14, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations