Clinical trial NCT05434624: QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the ICU
Official title: The Effect of Bispectral Index Controlled Sedation on QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator-Induced Lung Injury
Pulmonary Atelectasis
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For this study, it was planned to recruit 40 patients who would have FOB in the ICU of Abant İzzet Baysal University Anesthesia. All intubated patients over 18 years of age who do not meet the exclusion criteria will be included. 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: P wave dispersion (PWD)
timeFrame: Before the procedure
measure: P wave dispersion (PWD)
timeFrame: After the procedure of the first minute
measure: P wave dispersion (PWD)
timeFrame: After the procedure of the fifth minute
measure: P wave dispersion (PWD)
timeFrame: After the procedure of the tenth minute
measure: P wave dispersion (PWD)
timeFrame: After the procedure of the fifteenth minute
measure: QTc (Corrected QT interval) and QTd (QT dispersion) values
timeFrame: Before the procedure
measure: QTc (Corrected QT interval) and QTd (QT dispersion) values
timeFrame: After the procedure of the first minute
measure: QTc (Corrected QT interval) and QTd (QT dispersion) values
timeFrame: After the procedure of the fifth minute
measure: QTc (Corrected QT interval) and QTd (QT dispersion) values
timeFrame: After the procedure of the tenth minute
measure: QTc (Corrected QT interval) and QTd (QT dispersion) values
timeFrame: After the procedure of the fifteenth minute
Secondary outcomes:
measure: Hospitalization
timeFrame: Before the procedure
measure: Bronchoscopy duration
timeFrame: At the end of the procedure
measure: Systolic blood pressure (SBP)
timeFrame: Before the procedure
measure: Systolic blood pressure (SBP)
timeFrame: After the procedure of the first minute
measure: Systolic blood pressure (SBP)
timeFrame: After the procedure of the fifth minute
measure: Systolic blood pressure (SBP)
timeFrame: After the procedure of the tenth minute
measure: Systolic blood pressure (SBP)
timeFrame: After the procedure of the fifteenth minute
measure: Diastolic blood pressure (DBP)
timeFrame: Before the procedure
measure: Diastolic blood pressure (DBP)
timeFrame: After the procedure of the first minute
measure: Diastolic blood pressure (DBP)
timeFrame: After the procedure of the fifth minute
measure: Diastolic blood pressure (DBP)
timeFrame: After the procedure of the tenth minute
measure: Diastolic blood pressure (DBP)
timeFrame: After the procedure of the fifteenth minute
measure: Mean arterial pressure (MAP)
timeFrame: Before the procedure
measure: Mean arterial pressure (MAP)
timeFrame: After the procedure of the first minute
measure: Mean arterial pressure (MAP)
timeFrame: After the procedure of the fifth minute
measure: Mean arterial pressure (MAP)
timeFrame: After the procedure of the tenth minute
measure: Mean arterial pressure (MAP)
timeFrame: After the procedure of the fifteenth minute
measure: Heart rate (HR)
timeFrame: Before the procedure
measure: Heart rate (HR)
timeFrame: After the procedure of the first minute
measure: Heart rate (HR)
timeFrame: After the procedure of the fifth minute
measure: Heart rate (HR)
timeFrame: After the procedure of the tenth minute
measure: Heart rate (HR)
timeFrame: After the procedure of the fifteenth minute
measure: Central venous pressure (CVP)
timeFrame: Before the procedure
measure: Central venous pressure (CVP)
timeFrame: After the procedure of the first minute
measure: Central venous pressure (CVP)
timeFrame: After the procedure of the fifth minute
measure: Central venous pressure (CVP)
timeFrame: After the procedure of the tenth minute
measure: Central venous pressure (CVP)
timeFrame: After the procedure of the fifteenth minute
measure: Peripheral oxygen saturation
timeFrame: Before the procedure
measure: Peripheral oxygen saturation
timeFrame: After the procedure of the first minute
measure: Peripheral oxygen saturation
timeFrame: After the procedure of the fifth minute
measure: Peripheral oxygen saturation
timeFrame: After the procedure of the tenth minute
measure: Peripheral oxygen saturation
timeFrame: After the procedure of the fifteenth minute
measure: Airway pressure (P Peak)
timeFrame: Before the procedure
measure: Airway pressure (P Peak)
timeFrame: After the procedure of the first minute
measure: Airway pressure (P Peak)
timeFrame: After the procedure of the fifth minute
measure: Airway pressure (P Peak)
timeFrame: After the procedure of the tenth minute
measure: Airway pressure (P Peak)
timeFrame: After the procedure of the fifteenth minute
measure: Respiratory rate
timeFrame: Before the procedure
measure: Respiratory rate
timeFrame: After the procedure of the first minute
measure: Respiratory rate
timeFrame: After the procedure of the fifth minute
measure: Respiratory rate
timeFrame: After the procedure of the tenth minute
measure: Respiratory rate
timeFrame: After the procedure of the fifteenth minute
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant izzet baysal university
Study officials:
affiliation: Abant İzzet Baysal Üniversitesi University
name: Emine Ozsari
role: STUDY_DIRECTOR
References: