Extubation Times in Postoperative Congenital Cardiovascular Surgeries

Congenital Heart Disease Clinical Trial

Official title:

Evaluation of Factors Affecting Extubation Times in Postoperative Congenital Cardiovascular Surgeries: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332860
• Other study ID #: Bursa Education Hospital
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: March 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.

Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.

Description:

Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• elective or emergency patients

• aged 0-18 who are scheduled for congenital heart surgery

Exclusion Criteria:

-in patients who died during the operation

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Congenital Cardiovascular Surgery
Relationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital.

Locations

Country	Name	City	State
Turkey	Bursa Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extubation times	postoperative mechanical ventilation times	10 days after surgery
Secondary	mortality	mortality rates of groups	on 10 days