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

Ventilator-Induced Lung Injury Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05434624
• Other study ID #: BAIBU-MF-GH-EO-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: January 2023
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Pulmonary Atelectasis
• Ventilator-Induced Lung Injury

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Abant izzet baysal university	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P wave dispersion (PWD)	PWD in all leads will be measured manually with the X10 magnifying glass. The beginning of the P wave is the point where the isoelectric line and the P wave intersect. The endpoint was taken as the intersection of the isoelectric line and the end point of the P wave.ECG recordings of at least 6 QRS for each lead; 1 mV at a rate of 20 mm/s, including the complex 3 channels in amplitude and standard 12 leads will be done simultaneously.	Before the procedure
Primary	P wave dispersion (PWD)	PWD in all leads will be measured manually with the X10 magnifying glass. The beginning of the P wave is the point where the isoelectric line and the P wave intersect. The endpoint was taken as the intersection of the isoelectric line and the end point of the P wave.ECG recordings of at least 6 QRS for each lead 1 mV at a rate of 20 mm/s, including the complex 3 channels in amplitude and standard 12 leads will be done simultaneously.	After the procedure of the first minute
Primary	P wave dispersion (PWD)	PWD in all leads will be measured manually with the X10 magnifying glass. The beginning of the P wave is the point where the isoelectric line and the P wave intersect. The endpoint was taken as the intersection of the isoelectric line and the end point of the P wave.ECG recordings of at least 6 QRS for each lead 1 mV at a rate of 20 mm/s, including the complex 3 channels in amplitude and standard 12 leads will be done simultaneously.	After the procedure of the fifth minute
Primary	P wave dispersion (PWD)	PWD in all leads will be measured manually with the X10 magnifying glass. The beginning of the P wave is the point where the isoelectric line and the P wave intersect. The endpoint was taken as the intersection of the isoelectric line and the end point of the P wave.ECG recordings of at least 6 QRS for each lead 1 mV at a rate of 20 mm/s, including the complex 3 channels in amplitude and standard 12 leads will be done simultaneously.	After the procedure of the tenth minute
Primary	P wave dispersion (PWD)	PWD in all leads will be measured manually with the X10 magnifying glass. The beginning of the P wave is the point where the isoelectric line and the P wave intersect. The endpoint was taken as the intersection of the isoelectric line and the end point of the P wave.ECG recordings of at least 6 QRS for each lead 1 mV at a rate of 20 mm/s, including the complex 3 channels in amplitude and standard 12 leads will be done simultaneously.	After the procedure of the fifteenth minute
Primary	QTc (Corrected QT interval) and QTd (QT dispersion) values	The onset of the QRS complex and the descending T wave as the QT interval between the point where the arm cuts the isoelectric TP segment will be taken. QT dispersion (QTd) is the difference between the longest QT and the shortest QT interval. The heart rate-corrected value of the measurement of the QT interval will be used as the QTc. QTc > 500 ms means increased.	Before the procedure
Primary	QTc (Corrected QT interval) and QTd (QT dispersion) values	The onset of the QRS complex and the descending T wave as the QT interval between the point where the arm cuts the isoelectric TP segment will be taken. QT dispersion (QTd) is the difference between the longest QT and the shortest QT interval. The heart rate-corrected value of the measurement of the QT interval will be used as the QTc. QTc > 500 ms means increased.	After the procedure of the first minute
Primary	QTc (Corrected QT interval) and QTd (QT dispersion) values	The onset of the QRS complex and the descending T wave as the QT interval between the point where the arm cuts the isoelectric TP segment will be taken. QT dispersion (QTd) is the difference between the longest QT and the shortest QT interval. The heart rate-corrected value of the measurement of the QT interval will be used as the QTc. QTc > 500 ms means increased.	After the procedure of the fifth minute
Primary	QTc (Corrected QT interval) and QTd (QT dispersion) values	The onset of the QRS complex and the descending T wave as the QT interval between the point where the arm cuts the isoelectric TP segment will be taken. QT dispersion (QTd) is the difference between the longest QT and the shortest QT interval. The heart rate-corrected value of the measurement of the QT interval will be used as the QTc. QTc > 500 ms means increased.	After the procedure of the tenth minute
Primary	QTc (Corrected QT interval) and QTd (QT dispersion) values	The onset of the QRS complex and the descending T wave as the QT interval between the point where the arm cuts the isoelectric TP segment will be taken. QT dispersion (QTd) is the difference between the longest QT and the shortest QT interval. The heart rate-corrected value of the measurement of the QT interval will be used as the QTc. QTc > 500 ms means increased.	After the procedure of the fifteenth minute
Secondary	Hospitalization	The diagnosis of all patients will be noted on the first day of the ICU.	Before the procedure
Secondary	Bronchoscopy duration	The duration of the procedure will be noted from the beginning of the bronchoscopy till the end of it.	At the end of the procedure
Secondary	Systolic blood pressure (SBP)	SBP will be measured from the monitor.	Before the procedure
Secondary	Systolic blood pressure (SBP)	SBP will be measured from the monitor.	After the procedure of the first minute
Secondary	Systolic blood pressure (SBP)	SBP will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Systolic blood pressure (SBP)	SBP will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Systolic blood pressure (SBP)	SBP will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Diastolic blood pressure (DBP)	DBP will be measured from the monitor.	Before the procedure
Secondary	Diastolic blood pressure (DBP)	DBP will be measured from the monitor.	After the procedure of the first minute
Secondary	Diastolic blood pressure (DBP)	DBP will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Diastolic blood pressure (DBP)	DBP will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Diastolic blood pressure (DBP)	DBP will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Mean arterial pressure (MAP)	The MAP is the average of the systolic pressure and the diastolic pressure that is formulized as MAP = (SBP + [2x DBP]) / 3.	Before the procedure
Secondary	Mean arterial pressure (MAP)	The MAP is the average of the systolic pressure and the diastolic pressure that is formulized as MAP = (SBP + [2x DBP]) / 3.	After the procedure of the first minute
Secondary	Mean arterial pressure (MAP)	The MAP is the average of the systolic pressure and the diastolic pressure that is formulized as MAP = (SBP + [2x DBP]) / 3.	After the procedure of the fifth minute
Secondary	Mean arterial pressure (MAP)	The MAP is the average of the systolic pressure and the diastolic pressure that formulized as MAP = (SBP + [2x DBP]) / 3.	After the procedure of the tenth minute
Secondary	Mean arterial pressure (MAP)	The MAP is the average of the systolic pressure and the diastolic pressure that is formulized as MAP = (SBP + [2x DBP]) / 3.	After the procedure of the fifteenth minute
Secondary	Heart rate (HR)	The HR value will be measured from the monitor.	Before the procedure
Secondary	Heart rate (HR)	The HR value will be measured from the monitor.	After the procedure of the first minute
Secondary	Heart rate (HR)	The HR value will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Heart rate (HR)	The HR value will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Heart rate (HR)	The HR value will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Central venous pressure (CVP)	The CVP value will be measured from the monitor.	Before the procedure
Secondary	Central venous pressure (CVP)	The CVP value will be measured from the monitor.	After the procedure of the first minute
Secondary	Central venous pressure (CVP)	The CVP value will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Central venous pressure (CVP)	The CVP value will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Central venous pressure (CVP)	The CVP value will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Peripheral oxygen saturation	This will be measured from the monitor.	Before the procedure
Secondary	Peripheral oxygen saturation	This will be measured from the monitor.	After the procedure of the first minute
Secondary	Peripheral oxygen saturation	This will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Peripheral oxygen saturation	This will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Peripheral oxygen saturation	This will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Airway pressure (P Peak)	This will be measured from the monitor.	Before the procedure
Secondary	Airway pressure (P Peak)	This will be measured from the monitor.	After the procedure of the first minute
Secondary	Airway pressure (P Peak)	This will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Airway pressure (P Peak)	This will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Airway pressure (P Peak)	This will be measured from the monitor.	After the procedure of the fifteenth minute
Secondary	Respiratory rate	This will be measured from the monitor.	Before the procedure
Secondary	Respiratory rate	This will be measured from the monitor.	After the procedure of the first minute
Secondary	Respiratory rate	This will be measured from the monitor.	After the procedure of the fifth minute
Secondary	Respiratory rate	This will be measured from the monitor.	After the procedure of the tenth minute
Secondary	Respiratory rate	This will be measured from the monitor.	After the procedure of the fifteenth minute