Closed Aspiration on Hemodynamic Changes and Pain

Aspiration Clinical Trial

Official title:

Effects of Closed Aspiration on Hemodynamic Changes and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06143865
• Other study ID #: BU-SBF-EI-002
• Status: Completed
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 10, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Elif Günay Ismailoglu	Izmir	Menemen

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Bakircay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic status form 1	This form was used to record the arterial blood pressure of the patients.	1 minute after aspiration.
Primary	Hemodynamic status form 1	This form was used to record the respiratory rate of the patients.	1 minute after aspiration.
Primary	Hemodynamic status form 1	This form was used to record the oxygen saturation of the patients.	1 minute after aspiration.
Primary	Hemodynamic status form 1	This form was used to record the heart rate of the patients.	1 minute after aspiration.
Primary	Hemodynamic status form 2	This form was used to record the arterial blood pressure of the patients	5 minute after aspiration.
Primary	Hemodynamic status form 2	This form was used to record the heart rate of the patients.	5 minute after aspiration.
Primary	Hemodynamic status form 2	This form was used to record the respiratory rate of the patients.	5 minute after aspiration.
Primary	Hemodynamic status form 2	This form was used to record the oxygen saturation of the patients.	5 minute after aspiration.
Primary	Hemodynamic status form 3	This form was used to record the hemodynamic parameters arterial blood pressure of the patients.	30 minutes after aspiration.
Primary	Hemodynamic status form 3	This form was used to record the hemodynamic parameters heart rate of the patients.	30 minutes after aspiration.
Primary	Hemodynamic status form 3	This form was used to record the hemodynamic parameters the respiratory rate of the patients.	30 minutes after aspiration.
Primary	Hemodynamic status form 3	This form was used to record the hemodynamic parameters oxygen saturation of the patients.	30 minutes after aspiration.
Primary	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.
Primary	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.
Primary	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.