QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the ICU

NCT ID: NCT05434624

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-25
• Study Completion Date: 2024-03-25

Brief Summary

Fiberoptic bronchoscopy (FOB) is one of the most useful procedures for diagnosing and treating respiratory illnesses to figure out symptoms like hemoptysis, wheezing, or cough. Furthermore, FOB is a frequent method, in intensive care units, for both diagnoses of ventilator-associated pneumonia (VAP) and treatment of atelectasis with bedside sedation.) Propofol is often used in anesthesia for endoscopic treatments. Using propofol for deep anesthesia may be indicated to prevent the patient from feeling discomfort before FOB and to reduce the chance of complications.

Although major complications of FOB such as hypoxia and pneumothorax are known, there are limited studies showing its effects on cardiac hemodynamics. The cardiac effects of laryngoscope and intubation were investigated by using different anesthetic agents. In this study, we evaluated the effect of bronchoscopy with BIS-controlled sedation on ECG in ICU patients by monitoring the QT interval and P interval.

Detailed Description

For this study, it was planned to recruit 40 patients who would have FOB in the ICU of Abant İzzet Baysal University Anesthesia department. All intubated patients over 18 years of age who do not meet the exclusion criteria will be included. Before the procedure, all patients were given i.v. 0:02 - 0:04 mg / kg midazolam (zolamide 15 mg / 3 mL, and medications, Turkey) will be administered. Volume-controlled ventilation modes will be preferred during FOB. The pre-trade-inspired FiO2 will be increased to 100%. During the procedure, mean blood pressure, heart rate, oxygen saturation, respiratory rate, CVP, airway pressure, and BIS will be closely monitored. Enteral feeding will be discontinued at least 6 hours before the procedure. At the end of the procedure, the endotracheal tube position will be checked.

FOB will be performed using mobile bronchoscopy (Storz FB; 5.0 mm outer diameter). All patients will be monitored with BIS (Bispectral Index A-2000, Aspect Medical Systems, Netherlands) to measure the depth of sedation. Patients will be randomly divided into two groups by an anesthesiologist blinded to the study. Propofol will not be given to Group I after midazolam, while propofol 0.5 mg/kg bolus dose will be administered to Group II. Maintenance will be provided with 60 mcg/kg/min propofol infusion, and the propofol infusion dose will be increased by 10 mcg/kg/min by titration until the BIS value is 40-60 during the procedure. Patients under the age of 18, pregnancy, using sedative drugs in the last 24 hours, hypersensitivity to the drugs used in the study, severe cardiac disorder (EF: < 40), those who increase the QT interval (quinidine, lithium, procainamide, amiodarone, sotalol, phenothiazine, tricyclic Those who use antidepressants, disopyramide) or reducing (digitals) drugs, affecting QT such as hypomagnesemia- hypocalcemia - hypo or hyperthermia - hypo or hypercalcemia - hyperkalemia - hyper or hypothyroidism - myocarditis - mitral heart prolapse, etc. will be excluded from the study.

Patients will be randomly divided into 2 equal groups using the closed envelope method. Oral and written consent will be obtained from the first-degree relatives of all patients. All patients will be monitored with BIS to measure the depth of sedation. Age, weight - height, gender, medications used, comorbidities, hospitalization diagnosis, and duration of the procedure will be recorded for both groups. In addition, systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate, SpO2, BIS, respiratory rate, CVP, and airway pressure will be noted before and after the procedure of the first, fifth, tenth, and fifteenth minute. P wave dispersion, OTc, and OTd values will be calculated according to the max and min wavelengths as the primary outcomes.

Conditions

Ventilator-Induced Lung Injury; Pulmonary Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group M

Bronchoscopy group in which only midazolam will be used

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Before the procedure, all patients were given i.v. 0:02 - 0:04 mg / kg midazolam (zolamide 15 mg / 3 mL, and medications, Turkey) will be administered.

Group P

Bronchoscopy group in which midazolam and propofol will be used

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Propofol 0.5 mg/kg bolus dose will be administered to Group II. Maintenance will be provided with 60 mcg/kg/min propofol infusion, and the propofol infusion dose will be increased by 10 mcg/kg/min by titration until the BIS value is 40-60 during the procedure.

Interventions

Midazolam

Before the procedure, all patients were given i.v. 0:02 - 0:04 mg / kg midazolam (zolamide 15 mg / 3 mL, and medications, Turkey) will be administered.

Intervention Type: DRUG

Propofol

Propofol 0.5 mg/kg bolus dose will be administered to Group II. Maintenance will be provided with 60 mcg/kg/min propofol infusion, and the propofol infusion dose will be increased by 10 mcg/kg/min by titration until the BIS value is 40-60 during the procedure.

Intervention Type: DRUG

Other Intervention Names

Zolamid; Dormofol

Eligibility Criteria

Inclusion Criteria

• All intubated patients over 18 years of age

Exclusion Criteria

• Patients under the age of 18
• Pregnancy
• Patients using sedative drugs in the last 24 hours
• Hypersensitivity to the drugs used in the study
• Severe cardiac disorder (EF: < 40)
• Patients using drugs that increase the QT interval (quinidine, lithium, procainamide, amiodarone, sotalol, phenothiazine, tricyclic antidepressants, disopyramide) or reduce the QT interval (digitals)
• Patients who have hypomagnesemia- hypocalcemia - hypo or hyperthermia - hypo or hypercalcemia - hyperkalemia - hyper or hypothyroidism - myocarditis - mitral heart prolapsus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Emine Ozsari

Assistant professor, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine Ozsari

Role: STUDY_DIRECTOR

Abant İzzet Baysal Üniversitesi University

Locations

Abant izzet baysal university

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BAIBU-MF-GH-EO-001

Identifier Type: -

Identifier Source: org_study_id