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

NCT05434624 | Unknown

• 1 other identifier: BAIBU-MF-GH-EO-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Induced Lung Injury; Pulmonary Atelectasis

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (42)

• Hospitalization

  Before the procedure

• Bronchoscopy duration

  At the end of the procedure

• Systolic blood pressure (SBP)

  Before the procedure

• Systolic blood pressure (SBP)

  After the procedure of the first minute

• Systolic blood pressure (SBP)

  After the procedure of the fifth minute

Study Arms (2)

Group M

EXPERIMENTAL

Bronchoscopy group in which only midazolam will be used

Drug: Midazolam

Group P

EXPERIMENTAL

Bronchoscopy group in which midazolam and propofol will be used

Drug: Propofol

Interventions

Midazolam 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.

Also known as: Zolamid

Group M

Propofol 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.

Also known as: Dormofol

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* All intubated patients over 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant izzet baysal university

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Pulmonary Atelectasis

Interventions

Midazolam; Propofol

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Emine Ozsari

  Abant İzzet Baysal Üniversitesi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: June 25, 2022
• Primary Completion: December 25, 2023
• Study Completion: March 25, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)