- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03776292
Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position
18. června 2019 aktualizováno: Mohamed Abd Latif Ghanim, Mansoura University
Cardiopulmonary Effects of Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position During General Anesthesia
Introduction: Dynamic and static compliance should be calculated as a routine part of ventilator monitoring.
Dynamic and static compliance are 60-100 mL/cm H2O.
A decrease in dynamic compliance without a change in the static compliance suggests an acute increase in airway resistance and can be assessed further by comparing peak pressure and plateau pressure.
The normal gradient is approximately 10 cm H2O.
A gradient >10 cm H2O may be secondary to endotracheal tube obstruction, mucous plugging, or bronchospasm.
If volume is constant, acute changes in both dynamic and static compliance suggest a decrease in respiratory system compliance that may be caused by worsening increasing abdominal pressures.
When static compliance is <25 mL/cm H2O, ventilator weaning may be difficult secondary to tachypnea during spontaneous breathing trials.
(1) Aim of the work: to detect the cardiopulmonary burden of surgical ring retractors application during abdominal surgeries in supine versus lateral position (cancer bladder for supine position and open surgical nephrectomy for lateral position).
Hypothesis: Abdominal retractors application would produce more cardiopulmonary instability during lateral position than during supine position for abdominal surgery.
Patient & Methods: This comparative prospective randomized study, will be done on ASA I-II patients, both sexes, Age 18 - 65 year, to compare pulmonary compliance and cardiac performance before, during and after surgical self-retaining abdominal retractors application patients will be divided into 2 groups; 1st group (S) will undergo orthotropic cancer bladder diversion and the 2nd group (L) both supine and lateral position for open surgical nephrectomy for lateral position.
Přehled studie
Detailní popis
Introduction: Dynamic and static compliance should be calculated as a routine part of ventilator monitoring.
Dynamic and static compliance are 60-100 mL/cm H2O.
A decrease in dynamic compliance without a change in the static compliance suggests an acute increase in airway resistance and can be assessed further by comparing peak pressure and plateau pressure.
The normal gradient is approximately 10 cm H2O.
A gradient >10 cm H2O may be secondary to endotracheal tube obstruction, mucous plugging, or bronchospasm.
If volume is constant, acute changes in both dynamic and static compliance suggest a decrease in respiratory system compliance that may be caused by worsening increasing abdominal pressures.
When static compliance is <25 mL/cm H2O, ventilator weaning may be difficult secondary to tachypnea during spontaneous breathing trials.
(1) Aim of the work: to detect the cardiopulmonary burden of surgical ring retractors application during abdominal surgeries in supine versus lateral position (cancer bladder for supine position and open surgical nephrectomy for lateral position).
Hypothesis: Abdominal retractors application would produce more cardiopulmonary instability during lateral position than during supine position for abdominal surgery.
Patient & Methods: This comparative prospective randomized study, will be done on ASA I-II patients, both sexes, Age 18 - 65 year, to compare pulmonary compliance and cardiac performance before, during and after surgical self-retaining abdominal retractors application patients will be divided into 2 groups; 1st group (S) will undergo orthotropic cancer bladder diversion and the 2nd group (L) both supine and lateral position for open surgical nephrectomy for lateral position.
Study will be done at Mansoura University Hospital, during the year 2018, for 4 month duration, starting predected date=1-11-2018 actual study start date=15-12-2018[ NB. by mistake in the 1st registration i have regestered the study protocol predicted time of study start but actually the study started on 15-12-2018 thats why i changed the date more than one time ] till 30-3-2019 after approval of IRB (Institutional Review Board), Mansoura Faculty of Medicine.
Primary outcome; composite 1ry outcome [1-Dynamic pulmonary compliance.2-
Cardiac Index] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups.
Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index CPI, O2 delivery DIO2.
Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.
Typ studie
Pozorovací
Zápis (Aktuální)
40
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Dakahlia
-
Mansourah, Dakahlia, Egypt, 35511
- Mansoura faculty of Medicine- Mansoura Urology and nephrology center
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
-Patients admitted to the Urology Department, Mansoura Urology and Nephrology center, Faculty of medicine Mansoura University .
Popis
Inclusion Criteria:
- ASA I-II patients
- both sexes
- Age 18 - 65 year
- surgical time ≥ 6hours for Orthotopic urinary bladder diversion surgery for cancer bladder patients and 3 hours for open surgical nephrectomy.
Exclusion Criteria:
- Body mass index (BMI) greater than 35 kg. m-2.
- Asthma requiring bronchodilator therapy.
- Chronic Obstructive Pulmonary Disease, GOLD classification III and IV.
- Severe pulmonary disease.
- Hemodynamic instability (hypotension or tachycardia).
- History of congestive heart failure or New York Heart Association (NYHA) functional class IV
- Right ventricular dysfunction.
- Severe valvular heart disease.
- Intra-cardiac shunts.
- Intracranial hypertension.
- Cardiac rhythm other than regular sinus.
- Severe chronic kidney disease (glomerular filtration rate < 30 ml. min-1. 1.73 m2).
- Liver cirrhosis (Child Pugh class B or C).
- Pregnancy.
- Previous thoracic surgery (lobectomy, bilobectomy, or pneumonectomy).
- Lung metastatic surgery.
- Previous receiving chemotherapy.
- Emergency surgery.
- Preoperative need for invasive mechanical ventilation.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
supine position group= Group (S)
1st group of 20 patients will undergo urinary bladder cystectomy and orthotopic urinary diversion lying supine with ring abdominal retractors
|
Primary outcome; composite 1ry outcome [1-Dynamic pulmonary compliance monitoring.2-
Cardiac Index monitoring] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups.
Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2.
Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.
|
|
lateral position group = Group (L)
2nd group of 20 patients will undergo surgical open nephrectomy lying lateral position with self retaining abdominal retractors
|
Primary outcome; composite 1ry outcome [1-Dynamic pulmonary compliance monitoring.2-
Cardiac Index monitoring] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups.
Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2.
Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
-non invasive Dynamic pulmonary compliance .
Časové okno: mean dynamic compliance at minutes 30,60,90,120,180,210 240 post retractor application compared to mean dynamic compliance at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)
|
dynamic pulmonary compliance during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
mean dynamic compliance at minutes 30,60,90,120,180,210 240 post retractor application compared to mean dynamic compliance at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)
|
|
Non invasive Cardiac Index
Časové okno: mean Non invasive Cardiac Index at minutes 30,60,90,120,180,210 240 post retractor application compared to mean Non invasive Cardiac Index at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)
|
Cardiac index monitoring during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
mean Non invasive Cardiac Index at minutes 30,60,90,120,180,210 240 post retractor application compared to mean Non invasive Cardiac Index at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Static lung compliance
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Static lung compliance during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
Cardiac output.
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Cardiac output.
during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
Stroke volume SV
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Stroke volume SV. during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
- stroke volume variability (SVV)
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Stroke volume variability (SVV)during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
-Cardiac performance index CPI
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Cardiac performance index during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
Oxygen delivery DIO2
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Oxygen delivery DIO2 during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
. Noninvasive Intraoperative MBP
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Noninvasive Intraoperative MBP during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
HR
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
HR during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
|
arterial O2 saturation(SaO2%)
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
SaO2 saturation during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
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After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
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End tidal Co2 EtCO2
Časové okno: After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
End tidal Co2 EtCO2 during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
|
After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mohamed A. Ghanem, A professor, Mansoura Univeristy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
15. prosince 2018
Primární dokončení (Aktuální)
30. března 2019
Dokončení studie (Aktuální)
30. března 2019
Termíny zápisu do studia
První předloženo
9. prosince 2018
První předloženo, které splnilo kritéria kontroly kvality
12. prosince 2018
První zveřejněno (Aktuální)
14. prosince 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. června 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. června 2019
Naposledy ověřeno
1. června 2019
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- R.18.11.337
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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