Closed Aspiration on Hemodynamic Changes and Pain

Not Applicable

Completed

• Conditions: Aspiration
• Interventions: Other: Closed system aspiration

• Registration Number: NCT06143865
• Lead Sponsor: Izmir Bakircay University

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.

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 Timeline

• Study Start: 2022-07-10
• Primary Completion: 2022-11-10
• Study First Submitted: 2023-07-05
• Study Completion: 2023-10-10
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed aspiration group	Closed system aspiration	Closed system aspiration is performed according to standard guidelines for patients.

Primary Outcome Measures

Name	Time	Method
Hemodynamic status form 3	30 minutes after aspiration.	This form was used to record the hemodynamic parameters oxygen saturation of the patients.
Behavioral pain scale 2	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.
Behavioral pain scale 3	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.
Hemodynamic status form 1	1 minute after aspiration.	This form was used to record the heart rate of the patients.
Hemodynamic status form 2	5 minute after aspiration.	This form was used to record the oxygen saturation of the patients.
Behavioral pain scale 1	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.

Trial Locations

Locations (1)

Elif Günay İsmailoğlu; 🇹🇷 İzmir, Menemen, Turkey