Closed Aspiration on Hemodynamic Changes and Pain

Sponsor
Izmir Bakircay University (Other)
Overall Status
Completed
CT.gov ID
NCT06143865
Collaborator
(none)
67
1
1
15
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Closed system aspiration
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Closed Aspiration on Hemodynamic Changes and Pain
Actual Study Start Date :
Jul 10, 2022
Actual Primary Completion Date :
Nov 10, 2022
Actual Study Completion Date :
Oct 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Closed aspiration group

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

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.

Outcome Measures

Primary Outcome Measures

  1. Hemodynamic status form 1 [1 minute after aspiration.]

    This form was used to record the arterial blood pressure of the patients.

  2. Hemodynamic status form 1 [1 minute after aspiration.]

    This form was used to record the respiratory rate of the patients.

  3. Hemodynamic status form 1 [1 minute after aspiration.]

    This form was used to record the oxygen saturation of the patients.

  4. Hemodynamic status form 1 [1 minute after aspiration.]

    This form was used to record the heart rate of the patients.

  5. Hemodynamic status form 2 [5 minute after aspiration.]

    This form was used to record the arterial blood pressure of the patients

  6. Hemodynamic status form 2 [5 minute after aspiration.]

    This form was used to record the heart rate of the patients.

  7. Hemodynamic status form 2 [5 minute after aspiration.]

    This form was used to record the respiratory rate of the patients.

  8. Hemodynamic status form 2 [5 minute after aspiration.]

    This form was used to record the oxygen saturation of the patients.

  9. Hemodynamic status form 3 [30 minutes after aspiration.]

    This form was used to record the hemodynamic parameters arterial blood pressure of the patients.

  10. Hemodynamic status form 3 [30 minutes after aspiration.]

    This form was used to record the hemodynamic parameters heart rate of the patients.

  11. Hemodynamic status form 3 [30 minutes after aspiration.]

    This form was used to record the hemodynamic parameters the respiratory rate of the patients.

  12. Hemodynamic status form 3 [30 minutes after aspiration.]

    This form was used to record the hemodynamic parameters oxygen saturation of the patients.

  13. 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.

  14. 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.

  15. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elif Günay İsmailoğlu İzmir Menemen Turkey 35160

Sponsors and Collaborators

  • Izmir Bakircay University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Günay İsmailoğlu, Associate Professor, Izmir Bakircay University
ClinicalTrials.gov Identifier:
NCT06143865
Other Study ID Numbers:
  • BU-SBF-EI-002
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Günay İsmailoğlu, Associate Professor, Izmir Bakircay University

Study Results

No Results Posted as of Nov 22, 2023