Extubation Times in Postoperative Congenital Cardiovascular Surgeries

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16600
    • Bursa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

72 patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation times	postoperative mechanical ventilation times	10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality rates of groups	on 10 days

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Chair: Mesut M Engin, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Halil Erkan HE Sayan, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Şeyda Efsun ŞE Özgünay, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Nermin N Kılıçarslan, MD, Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: extubation; Congenital heart disease; pediatric cardiac surgery; perioperative management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Bursa Education Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No