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- Essai clinique NCT03776292
Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position
18 juin 2019 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
40
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Dakahlia
-
Mansourah, Dakahlia, Egypte, 35511
- Mansoura faculty of Medicine- Mansoura Urology and nephrology center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
-Patients admitted to the Urology Department, Mansoura Urology and Nephrology center, Faculty of medicine Mansoura University .
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
-non invasive Dynamic pulmonary compliance .
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Static lung compliance
Délai: 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.
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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%)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mohamed A. Ghanem, A professor, Mansoura Univeristy
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 décembre 2018
Achèvement primaire (Réel)
30 mars 2019
Achèvement de l'étude (Réel)
30 mars 2019
Dates d'inscription aux études
Première soumission
9 décembre 2018
Première soumission répondant aux critères de contrôle qualité
12 décembre 2018
Première publication (Réel)
14 décembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- R.18.11.337
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .