Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position
Cardiopulmonary Effects of Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position During General Anesthesia
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Kontakte und Standorte
Studienorte
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Dakahlia
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Mansourah, Dakahlia, Ägypten, 35511
- Mansoura faculty of Medicine- Mansoura Urology and nephrology center
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Anzahl der Gruppen / Kohorten
Kohorten und Interventionen
Gruppe / KohorteGruppe / Kohorte |
Intervention / BehandlungIntervention / Behandlung |
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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
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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.
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lateral position group = Group (L)
2nd group of 20 patients will undergo surgical open nephrectomy lying lateral position with self retaining abdominal retractors
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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-non invasive Dynamic pulmonary compliance .
Zeitfenster: 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)
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dynamic pulmonary compliance during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
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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)
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Non invasive Cardiac Index
Zeitfenster: 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)
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Cardiac index monitoring during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups
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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)
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Static lung compliance
Zeitfenster: 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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Static lung compliance 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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Cardiac output.
Zeitfenster: 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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Cardiac output.
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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Stroke volume SV
Zeitfenster: 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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Stroke volume SV. 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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- stroke volume variability (SVV)
Zeitfenster: 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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Stroke volume variability (SVV)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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-Cardiac performance index CPI
Zeitfenster: 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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Cardiac performance index 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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Oxygen delivery DIO2
Zeitfenster: 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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Oxygen delivery DIO2 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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. Noninvasive Intraoperative MBP
Zeitfenster: 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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Noninvasive Intraoperative MBP 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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HR
Zeitfenster: 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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HR 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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arterial O2 saturation(SaO2%)
Zeitfenster: 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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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
Zeitfenster: 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 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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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Mohamed A. Ghanem, A professor, Mansoura Univeristy
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- R.18.11.337
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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