Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery

NCT05820789 | Completed

• 1 other identifier: 2022-KAEK-146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Patient Comfort; Anxiety; Patient Satisfaction

Keywords

Weaning; Patient satisfaction; Anxiety; Family support; Cardiac surgery

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (1)

• The Visual Analog Scale

  10 minutes after weaning procedure

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Family support OTHER

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.

Also known as: Experimantal group

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University

Kastamonu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Selda Karaveli Cakir

  Kastamonu Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 20, 2023
• Study Start: April 30, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 20, 2024
• Last Updated: March 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)