Closed Aspiration on Hemodynamic Changes and Pain

Effects of Closed Aspiration on Hemodynamic Changes and Pain

The study was planned to determine the effects of closed aspiration on arterial blood pressure, heart rate, respiratory rate, oxygen saturation level and pain in intensive care patients connected to mechanical ventilators. IThe effects of the closed aspiration system on hemodynamic parameters and pain will be determined and the results will be important in terms of the usability of the closed system in the clinical environment and raising awareness in nursing practices in order to create minimum complications for the patient.

Study Overview

• Status: Completed
• Conditions: Aspiration
• Intervention / Treatment: Procedure: Closed system aspiration

Detailed Description

The research iss carried out in a single group pretest posttest quasi-experimental design in order to determine the effects of closed aspiration on arterial blood pressure, heart rate, respiratory rate, oxygen saturation level and pain in intensive care unit patients with mechanical ventilation. The research is carried out in Anesthesiology and Reanimation Intensive Care Unit. The sample of the study is patients who was intubated, not sedated, systolic arterial blood pressure 110-140 mmHg, diastolic arterial blood pressure between 60-90 mmHg, heart rate between 60-100/min, respiratory rate between 12-20/min, oxygen with saturation level (SpO2) >86%. Data is collected from the hospital's electronic patient record system and observationally before and after the aspiration. "Patient Description Form", "Hemodynamic Status and Pain Monitoring Form", "Behavioral Pain Scale" is used to collect research data.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Menemen
    • Izmir, Menemen, Turkey (Türkiye), 35160
      • Elif Günay İsmailoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• over 18 years,
• Intubated
• Connected to mechanical ventilator,
• Not receiving sedation,
• Not unconscious,
• Monitored,
• Systolic arterial blood pressure is between 110-140 mmHg and diastolic arterial blood pressure is between 60-90 mmHg,
• Heart rate between 60-100/min,
• Respiratory rate between 12-20/min,
• Body temperature not higher than 38º C,
• Oxygen saturation level (SpO2) >86%

Exclusion Criteria:

• Not intubated,
• Received a diagnosis related to the respiratory system,
• Unconscious or sedated curare

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed aspiration group; Closed system aspiration is performed according to standard guidelines for patients.	Procedure: Closed system aspiration; Aspiration catheter; it is part of the ventilator and the ventilator circuit. The catheter is stored in a protective sheath. Therefore, the catheter can be used repeatedly during the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral pain scale 1	It consists of three items: facial expression, upper extremities, and compliance with the ventilator. For each item, there are four variables that include behavioral responses to pain. Each section is given a score between 1-4. The score obtained from the scale is between 3-12. Higher scores indicate increased pain intensity.	1st after aspiration.
Behavioral pain scale 2	It consists of three items: facial expression, upper extremities, and compliance with the ventilator. For each item, there are four variables that include behavioral responses to pain. Each section is given a score between 1-4. The score obtained from the scale is between 3-12. Higher scores indicate increased pain intensity.	5th minutes after aspiration.
Behavioral pain scale 3	It consists of three items: facial expression, upper extremities, and compliance with the ventilator. For each item, there are four variables that include behavioral responses to pain. Each section is given a score between 1-4. The score obtained from the scale is between 3-12. Higher scores indicate increased pain intensity.	30th minutes after aspiration.
Hemodynamic status form 1	This form was used to record the arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients.	1 minute after aspiration.
Hemodynamic status form 2	This form was used to record the arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients	5 minute after aspiration.
Hemodynamic status form 3	This form was used to record the hemodynamic parameters arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients.	30 minutes after aspiration.

Collaborators and Investigators

• Sponsor: Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Hemodynamic parameters; Closed aspiration
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: BU-SBF-EI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No