Extubation Times in Postoperative Congenital Cardiovascular Surgeries

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05332860

Collaborator

(none)

Enrollment

Location

9.5

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Procedure: Congenital Cardiovascular Surgery

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

72 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Immediate Extubation or IE patients were extubated in the operating room (OR) or in 6 hours after surgery	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.
Early Extubation or EE patients were extubated within 6-48 hours of admission to the ICU	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.
Delayed Extubation or DE patients were extubated sometime after 48 hours or not extubated	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.

Arm

Intervention/Treatment

Immediate Extubation or IE

patients were extubated in the operating room (OR) or in 6 hours after surgery

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.

Early Extubation or EE

patients were extubated within 6-48 hours of admission to the ICU

Procedure: Congenital Cardiovascular Surgery

Delayed Extubation or DE

patients were extubated sometime after 48 hours or not extubated

Procedure: Congenital Cardiovascular Surgery

Outcome Measures

Primary Outcome Measures

extubation times [10 days after surgery]
postoperative mechanical ventilation times

Secondary Outcome Measures

mortality [on 10 days]
mortality rates of groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa Training and Research Hospital	Bursa		Turkey	16600

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Principal Investigator: Tuğba T Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Ümran Ü Karaca, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Anıl A Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Serkan S Seçici, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Selimcan S Yırtımcı, MD, Bursa Yüksek İhtisas Education and Research Hospital