Closed Aspiration on Hemodynamic Changes and Pain

NCT06143865 | Completed

• 1 other identifier: BU-SBF-EI-002
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aspiration

Keywords

Closed aspiration; Pain; Hemodynamic parameters

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

Study Arms (1)

Closed aspiration group

EXPERIMENTAL

Closed system aspiration is performed according to standard guidelines for patients.

Procedure: Closed system aspiration

Interventions

Closed system aspiration PROCEDURE

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.

Closed aspiration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Elif Günay İsmailoğlu

Izmir, Menemen, 35160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Associate Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: November 22, 2023
• Study Start: July 10, 2022
• Primary Completion: November 10, 2022
• Study Completion: October 10, 2023
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)