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Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position

18 juni 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

40

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Dakahlia
      • Mansourah, Dakahlia, Egypte, 35511
        • Mansoura faculty of Medicine- Mansoura Urology and nephrology center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

-Patients admitted to the Urology Department, Mansoura Urology and Nephrology center, Faculty of medicine Mansoura University .

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
-non invasive Dynamic pulmonary compliance .
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Static lung compliance
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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%)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Mohamed A. Ghanem, A professor, Mansoura Univeristy

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 december 2018

Primaire voltooiing (Werkelijk)

30 maart 2019

Studie voltooiing (Werkelijk)

30 maart 2019

Studieregistratiedata

Eerst ingediend

9 december 2018

Eerst ingediend dat voldeed aan de QC-criteria

12 december 2018

Eerst geplaatst (Werkelijk)

14 december 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • R.18.11.337

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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