- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03776292
Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position
18. Juni 2019 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
40
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Dakahlia
-
Mansourah, Dakahlia, Ägypten, 35511
- Mansoura faculty of Medicine- Mansoura Urology and nephrology center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
-Patients admitted to the Urology Department, Mansoura Urology and Nephrology center, Faculty of medicine Mansoura University .
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
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
-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)
|
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
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)
|
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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
|
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.
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
|
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
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
|
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)
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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%)
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
|
SaO2 saturation 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
|
|
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
|
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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mohamed A. Ghanem, A professor, Mansoura Univeristy
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Dezember 2018
Primärer Abschluss (Tatsächlich)
30. März 2019
Studienabschluss (Tatsächlich)
30. März 2019
Studienanmeldedaten
Zuerst eingereicht
9. Dezember 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Dezember 2018
Zuerst gepostet (Tatsächlich)
14. Dezember 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. Juni 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Juni 2019
Zuletzt verifiziert
1. Juni 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- R.18.11.337
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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