Ventilator-Induced Lung InjuryNCT05434624
QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the ICU
A study testing Midazolam and Propofol in people with Ventilator-Induced Lung Injury and Pulmonary Atelectasis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury, Pulmonary Atelectasis
- What is being tested?
- Midazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2022to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated patients over 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Medical subject headings
- Ventilator-Induced Lung Injury, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Zolamid
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.
PropofolDrug
Also called Dormofol
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.
| Study group | Role | What they receive |
|---|---|---|
| Group M | Experimental | Bronchoscopy group in which only midazolam will be used Receives: Drug: Midazolam |
| Group P | Experimental | Bronchoscopy group in which midazolam and propofol will be used Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the procedure of the fifteenth minute
Secondary outcomes (42)
Hospitalization
The diagnosis of all patients will be noted on the first day of the ICU.
Measured: Before the procedure
Bronchoscopy duration
The duration of the procedure will be noted from the beginning of the bronchoscopy till the end of it.
Measured: At the end of the procedure
Systolic blood pressure (SBP)
SBP will be measured from the monitor.
Measured: Before the procedure
Systolic blood pressure (SBP)
SBP will be measured from the monitor.
Measured: After the procedure of the first minute
Systolic blood pressure (SBP)
SBP will be measured from the monitor.
Measured: After the procedure of the fifth minute
Systolic blood pressure (SBP)
SBP will be measured from the monitor.
Measured: After the procedure of the tenth minute
Systolic blood pressure (SBP)
SBP will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Diastolic blood pressure (DBP)
DBP will be measured from the monitor.
Measured: Before the procedure
Diastolic blood pressure (DBP)
DBP will be measured from the monitor.
Measured: After the procedure of the first minute
Diastolic blood pressure (DBP)
DBP will be measured from the monitor.
Measured: After the procedure of the fifth minute
Diastolic blood pressure (DBP)
DBP will be measured from the monitor.
Measured: After the procedure of the tenth minute
Diastolic blood pressure (DBP)
DBP will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
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.
Measured: Before the procedure
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.
Measured: After the procedure of the first minute
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.
Measured: After the procedure of the fifth minute
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.
Measured: After the procedure of the tenth minute
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.
Measured: After the procedure of the fifteenth minute
Heart rate (HR)
The HR value will be measured from the monitor.
Measured: Before the procedure
Heart rate (HR)
The HR value will be measured from the monitor.
Measured: After the procedure of the first minute
Heart rate (HR)
The HR value will be measured from the monitor.
Measured: After the procedure of the fifth minute
Heart rate (HR)
The HR value will be measured from the monitor.
Measured: After the procedure of the tenth minute
Heart rate (HR)
The HR value will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Central venous pressure (CVP)
The CVP value will be measured from the monitor.
Measured: Before the procedure
Central venous pressure (CVP)
The CVP value will be measured from the monitor.
Measured: After the procedure of the first minute
Central venous pressure (CVP)
The CVP value will be measured from the monitor.
Measured: After the procedure of the fifth minute
Central venous pressure (CVP)
The CVP value will be measured from the monitor.
Measured: After the procedure of the tenth minute
Central venous pressure (CVP)
The CVP value will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Peripheral oxygen saturation
This will be measured from the monitor.
Measured: Before the procedure
Peripheral oxygen saturation
This will be measured from the monitor.
Measured: After the procedure of the first minute
Peripheral oxygen saturation
This will be measured from the monitor.
Measured: After the procedure of the fifth minute
Peripheral oxygen saturation
This will be measured from the monitor.
Measured: After the procedure of the tenth minute
Peripheral oxygen saturation
This will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Airway pressure (P Peak)
This will be measured from the monitor.
Measured: Before the procedure
Airway pressure (P Peak)
This will be measured from the monitor.
Measured: After the procedure of the first minute
Airway pressure (P Peak)
This will be measured from the monitor.
Measured: After the procedure of the fifth minute
Airway pressure (P Peak)
This will be measured from the monitor.
Measured: After the procedure of the tenth minute
Airway pressure (P Peak)
This will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Respiratory rate
This will be measured from the monitor.
Measured: Before the procedure
Respiratory rate
This will be measured from the monitor.
Measured: After the procedure of the first minute
Respiratory rate
This will be measured from the monitor.
Measured: After the procedure of the fifth minute
Respiratory rate
This will be measured from the monitor.
Measured: After the procedure of the tenth minute
Respiratory rate
This will be measured from the monitor.
Measured: After the procedure of the fifteenth minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start25 Jun 2022
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Ozsari, Abant Izzet Baysal University
- Investigators
- Emine Ozsari, Study director, Abant İzzet Baysal Üniversitesi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434624
- Sponsor's protocol ID
- BAIBU-MF-GH-EO-001
- Status last verified
- Jan 2023
- First submitted
- 22 Jun 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05434624
- Acronym / sponsor ID
- BAIBU-MF-GH-EO-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Mar 2024 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group M | Experimental | Drug: MidazolamBronchoscopy group in which only midazolam will be used |
| Group P | Experimental | Drug: PropofolBronchoscopy group in which midazolam and propofol will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All intubated patients over 18 years of age
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: ZolamidBefore 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. | Drug | Group M |
| PropofolAlso: DormofolPropofol 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. | Drug | Group P |
Primary outcome
P wave dispersion (PWD)
Time frame: Before the procedure
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.
P wave dispersion (PWD)
Time frame: After the procedure of the first minute
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.
P wave dispersion (PWD)
Time frame: After the procedure of the fifth minute
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.
P wave dispersion (PWD)
Time frame: After the procedure of the tenth minute
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.
P wave dispersion (PWD)
Time frame: After the procedure of the fifteenth minute
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.
QTc (Corrected QT interval) and QTd (QT dispersion) values
Time frame: Before the procedure
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.
QTc (Corrected QT interval) and QTd (QT dispersion) values
Time frame: After the procedure of the first minute
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.
QTc (Corrected QT interval) and QTd (QT dispersion) values
Time frame: After the procedure of the fifth minute
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.
QTc (Corrected QT interval) and QTd (QT dispersion) values
Time frame: After the procedure of the tenth minute
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.
QTc (Corrected QT interval) and QTd (QT dispersion) values
Time frame: After the procedure of the fifteenth minute
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.
42 secondary outcomes
Hospitalization
Time frame: Before the procedure
Bronchoscopy duration
Time frame: At the end of the procedure
Systolic blood pressure (SBP)
Time frame: Before the procedure
Systolic blood pressure (SBP)
Time frame: After the procedure of the first minute
Systolic blood pressure (SBP)
Time frame: After the procedure of the fifth minute
Systolic blood pressure (SBP)
Time frame: After the procedure of the tenth minute
Systolic blood pressure (SBP)
Time frame: After the procedure of the fifteenth minute
Diastolic blood pressure (DBP)
Time frame: Before the procedure
Diastolic blood pressure (DBP)
Time frame: After the procedure of the first minute
Diastolic blood pressure (DBP)
Time frame: After the procedure of the fifth minute
Diastolic blood pressure (DBP)
Time frame: After the procedure of the tenth minute
Diastolic blood pressure (DBP)
Time frame: After the procedure of the fifteenth minute
Mean arterial pressure (MAP)
Time frame: Before the procedure
Mean arterial pressure (MAP)
Time frame: After the procedure of the first minute
Mean arterial pressure (MAP)
Time frame: After the procedure of the fifth minute
Mean arterial pressure (MAP)
Time frame: After the procedure of the tenth minute
Mean arterial pressure (MAP)
Time frame: After the procedure of the fifteenth minute
Heart rate (HR)
Time frame: Before the procedure
Heart rate (HR)
Time frame: After the procedure of the first minute
Heart rate (HR)
Time frame: After the procedure of the fifth minute
Heart rate (HR)
Time frame: After the procedure of the tenth minute
Heart rate (HR)
Time frame: After the procedure of the fifteenth minute
Central venous pressure (CVP)
Time frame: Before the procedure
Central venous pressure (CVP)
Time frame: After the procedure of the first minute
Central venous pressure (CVP)
Time frame: After the procedure of the fifth minute
Central venous pressure (CVP)
Time frame: After the procedure of the tenth minute
Central venous pressure (CVP)
Time frame: After the procedure of the fifteenth minute
Peripheral oxygen saturation
Time frame: Before the procedure
Peripheral oxygen saturation
Time frame: After the procedure of the first minute
Peripheral oxygen saturation
Time frame: After the procedure of the fifth minute
Peripheral oxygen saturation
Time frame: After the procedure of the tenth minute
Peripheral oxygen saturation
Time frame: After the procedure of the fifteenth minute
Airway pressure (P Peak)
Time frame: Before the procedure
Airway pressure (P Peak)
Time frame: After the procedure of the first minute
Airway pressure (P Peak)
Time frame: After the procedure of the fifth minute
Airway pressure (P Peak)
Time frame: After the procedure of the tenth minute
Airway pressure (P Peak)
Time frame: After the procedure of the fifteenth minute
Respiratory rate
Time frame: Before the procedure
Respiratory rate
Time frame: After the procedure of the first minute
Respiratory rate
Time frame: After the procedure of the fifth minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Ventilator-Induced Lung Injury
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Ozsari study director
Abant İzzet Baysal Üniversitesi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Propofol in people with Ventilator-Induced Lung Injury and Pulmonary Atelectasis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P wave dispersion (PWD) (time frame: Before the procedure). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.