Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery

Sponsor
Kastamonu University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05820789
Collaborator
(none)
40
2
4.7

Study Details

Study Description

Brief Summary

Mechanical ventilation support is used to ensure airway clarity in patients after surgery.If patients are not informed about mechanical ventilation treatment in the pre -operation period, panic, anxiety and comfort may be experienced when they wake up from anesthesia and find them in intensive care under mechanical ventilation with various tubes and equipment. The separation from the mechanical ventilator (MV) covers the patient's mechanical support and the entire process of separation of endotrakeal tube.During the separation of the mechanical ventilator, the support of one of the patient members of the patient may increase the stress and comfort of the patient. Therefore, this research is planned

Condition or Disease Intervention/Treatment Phase
  • Other: Family support
N/A

Detailed Description

Intensive care nurses spend a long time with patients and observe them closely. Intensive care nurses in the MV separation process; plays a special and important role. Recently, family support has been used in patient care. An increase in anxiety and comfort levels is observed in patients receiving family support. This study was planned with the aim of supporting the patient by the family member during the separation of the patient from the mechanical ventilator after cardiac surgery and to evaluate the comfort and anxiety level of the patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Family Support on Hemodynamic Parameter, Comfort and Anxiety Level in Weaning From Mechanical Ventilation in Cardiovascular Surgery: A Randomized Controlled Study
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Sep 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

When the patient comes intubated from the surgery to the cardiovascular surgery intensive care unit, when they meet the extubation criteria, the patients will be extubated by the healthcare professionals working in the intensive care unit in accordance with the service protocol.Patients in the experimental group will be provided with their relatives and support during weaning from the mechanical ventilator.

Other: Family support
Before the extubation procedure, the patient's relatives will be informed, and the patient will be allowed to enter the intensive care unit, and the patient will be able to express that he is with the patient by holding his hand and talking.
Other Names:
  • Experimantal group
  • No Intervention: Control Group

    Patient comes intubated from the surgery to the cardiovascular surgery intensive care unit, when they meet the extubation criteria, the patients will be extubated by the healthcare professionals working in the intensive care unit in accordance with the service protocol.

    Outcome Measures

    Primary Outcome Measures

    1. State Anxiety [30 minutes before the weaning procedure.]

      State Anxiety Inventory was used to assess state anxiety. The Turkish validity and reliability of the scale were undertaken by Oner and Le Compte . The state anxiety scale composed of 20-items that shows how a person feels at a certain moment and under certain conditions. The scale score ranges from 20 to 80, with a high scores indicating high anxiety.

    2. State Anxiety [after 30 minutes the weaning procedure.]

      State Anxiety Inventory was used to assess state anxiety. The Turkish validity and reliability of the scale were undertaken by Oner and Le Compte. The state anxiety scale composed of 20-items that shows how a person feels at a certain moment and under certain conditions. The scale score ranges from 20 to 80, with a high scores indicating high anxiety.

    3. Perianesthesia Comfort [on the 1st day after surgery]

      This scale was developed by Kolcaba in 2003, and its Turkish validity and reliability were made by Üstündağ and Eti Aslan in 2010. It is used to evaluate the situation of reaching the expected increase in comfort by determining the comfort requirements. The scale consists of 24 items that question the self-concept and feelings of the individual reflecting the general thought process before and after the surgical intervention. The scale score ranges from 24 to 144, with a high scores indicating high comfort.

    4. Patient's systolic blood pressure (mmHg) [10 minutes before weaning]

      before weaning 1

    5. Diastolic blood pressures (mmHg) [10 minutes before weaning]

      before weaning 2

    6. Heart rate (per minute) [10 miniutes before weaning procedure]

      before weaning 3

    7. Oxygen saturation (SpO2) [10 miniutes before weaning procedure]

      before weaning 4

    8. Patient's systolic blood pressure (mmHg) - after weaning 1 [10 miniutes after weaning procedure]

      Patient's systolic blood pressure (mmHg)

    9. Diastolic blood pressures (mmHg) after weaning 2 [10 miniutes after weaning procedure]

      Diastolic blood pressures (mmHg)

    10. Heart rate (per minute) - after weaning 3 [10 miniutes after weaning procedure]

      Heart rate (per minute)

    11. Oxygen saturation (SpO2) - after weaning 4 [10 miniutes after weaning procedure]

      Oxygen saturation (SpO2)

    Secondary Outcome Measures

    1. The Visual Analog Scale [10 minutes after weaning procedure]

      A 10-centimeter vertical VAS was used to assess the satisfaction assessment by patients after weaning procedure. The scale score ranges from 0 to 10, with a high scores indicating high satisfaction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Volunteering to participate in the research

    • To agree to participate in the research verbally and in writing

    • To be over the age of 18

    • Knowing Turkish

    • Not having any psychiatric disease

    • No vision, hearing and perception problems

    • Receiving mechanical ventilator support after cardiac surgery and being followed in the intensive care unit.

    Exclusion Criteria:
    • Patients who do not meet the inclusion criteria

    • Other patients receiving mechanical ventilator support after surgery in the intensive care unit other than cardiac surgery

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kastamonu University

    Investigators

    • Principal Investigator: Selda Karaveli Cakir, Kastamonu Universty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Selda Karaveli Çakır, Assistant professor, Kastamonu University
    ClinicalTrials.gov Identifier:
    NCT05820789
    Other Study ID Numbers:
    • 2022-KAEK-146
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 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 Selda Karaveli Çakır, Assistant professor, Kastamonu University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2023