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NCT Number: NCT06143865

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.

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Key information

Conditions

Aspiration Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elif Günay İsmailoğlu

Izmir, Menemen, 35160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hemodynamic status form 1

    Time frame: 1 minute after aspiration.

    This form was used to record the arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients.

  2. Hemodynamic status form 2

    Time frame: 5 minute after aspiration.

    This form was used to record the arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients

  3. Hemodynamic status form 3

    Time frame: 30 minutes after aspiration.

    This form was used to record the hemodynamic parameters arterial blood pressure, respiratory rate, oxygen saturation, heart rate of the patients.

  4. Behavioral pain scale 1

    Time frame: 1st after aspiration.

    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.

  5. Behavioral pain scale 2

    Time frame: 5th minutes after aspiration.

    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.

  6. Behavioral pain scale 3

    Time frame: 30th minutes after aspiration.

    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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

Effects of Closed Aspiration on Hemodynamic Changes and Pain

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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