Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Family Support on Hemodynamic Parameter, Comfort and Anxiety Level in Weaning From Mechanical Ventilation in Cardiovascular Surgery: A Randomized Controlled Study

Conditions
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Anxiety, Patient Comfort, Patient Satisfaction

Intervention / Treatment
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* Other: Family support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* 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.<br>* Other names: Experimantal group;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Anxiety | 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. | 30 minutes before the weaning procedure. | 
| State Anxiety | 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. | after 30 minutes the weaning procedure. | 
| Perianesthesia Comfort | 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. | on the 1st day after surgery | 
| Patient's systolic blood pressure (mmHg) | before weaning 1 | 10 minutes before weaning | 
| Diastolic blood pressures (mmHg) | before weaning 2 | 10 minutes before weaning | 
| Heart rate (per minute) | before weaning 3 | 10 miniutes before weaning procedure | 
| Oxygen saturation (SpO2) | before weaning 4 | 10 miniutes before weaning procedure | 
| Patient's systolic blood pressure (mmHg) - after weaning 1 | Patient's systolic blood pressure (mmHg) | 10 miniutes after weaning procedure | 
| Diastolic blood pressures (mmHg) after weaning 2 | Diastolic blood pressures (mmHg) | 10 miniutes after weaning procedure | 
| Heart rate (per minute) - after weaning 3 | Heart rate (per minute) | 10 miniutes after weaning procedure | 
| Oxygen saturation (SpO2) - after weaning 4 | Oxygen saturation (SpO2) | 10 miniutes after weaning procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Visual Analog Scale | 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. | 10 minutes after weaning procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning, Patient satisfaction, Anxiety, Family support, Cardiac surgery