Nctid:
NCT06612125
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M9625", "name"=>"Hernia", "relevance"=>"LOW"}, {"id"=>"M9630", "name"=>"Hernia, Inguinal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>78}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-21", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"(PIP)", "timeFrame"=>"within one hour", "description"=>"peak inspiratory pressure"}, {"measure"=>"Pplat", "timeFrame"=>"within one hour", "description"=>"plateau airway pressure"}, {"measure"=>"(Cdyn)", "timeFrame"=>"within one hour", "description"=>"pulmonary dynamic compliance"}, {"measure"=>"(RAW", "timeFrame"=>"within one hour", "description"=>"airway resistance"}, {"measure"=>"VT", "timeFrame"=>"within one hour", "description"=>"exhaled tidal volume"}, {"measure"=>"EtCO2", "timeFrame"=>"within one hour", "description"=>"end-expiratory carbon dioxide"}, {"measure"=>"Vd/VT", "timeFrame"=>"within one hour", "description"=>"physiologic dead space over tidal volume"}], "secondaryOutcomes"=>[{"measure"=>"(MAP)", "timeFrame"=>"within one hour", "description"=>"mean arterial pressure"}, {"measure"=>"(HR)", "timeFrame"=>"within one hour", "description"=>"heart rate"}, {"measure"=>"postoperative respiratory adverse events", "timeFrame"=>"within 24 hour", "description"=>"cough, hoarseness, sore throat, hypoxemia, laryngospasm, bronchospasm."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Ventilation Therapy; Complications"]}, "descriptionModule"=>{"briefSummary"=>"The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,", "detailedDescription"=>"The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"5 years", "minimumAge"=>"1 year", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. age between 1 and 5 years.\n2. patient scheduled for laparoscopic inguinal hernia repair.\n3. American Society of Anesthesiologists classification of physical status of I-II.\n\nExclusion Criteria:\n\n1. cardiopulmonary disease.\n2. severe hepatorenal dysfunction.\n3. history of upper respiratory tract infection 2 weeks before the operation.\n4. overweight \\[more than 20% of standard body weight\\].\n5. neuromuscular disease.\n6. anticipated difficult airway.\n7. hiatus hernia or gastroesophageal reflux disease."}, "identificationModule"=>{"nctId"=>"NCT06612125", "briefTitle"=>"Comparing Different Startegies of Positive Pressure Ventilation in Children", "organization"=>{"class"=>"OTHER", "fullName"=>"Beni-Suef University"}, "officialTitle"=>"Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study", "orgStudyIdInfo"=>{"id"=>"FMBSUREC/01092024/Mansour"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"vCV group", "description"=>"Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.", "interventionNames"=>["Other: volume controlled ventilation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"PCV group", "description"=>"Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.", "interventionNames"=>["Other: pressure controlled ventilation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"PCV-VG group", "description"=>"Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.", "interventionNames"=>["Other: pressure controlled volume grantanteed ventilation"]}], "interventions"=>[{"name"=>"volume controlled ventilation", "type"=>"OTHER", "description"=>"Pediatric patients in the VCV group (n= 30) received volume-controlled ventilation, target tidal volume was set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.", "armGroupLabels"=>["vCV group"]}, {"name"=>"pressure controlled ventilation", "type"=>"OTHER", "description"=>"Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.", "armGroupLabels"=>["PCV group"]}, {"name"=>"pressure controlled volume grantanteed ventilation", "type"=>"OTHER", "description"=>"Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.", "armGroupLabels"=>["PCV-VG group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Benisuef", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Mariana As Mansour, MD", "role"=>"CONTACT", "email"=>"mrmrsyk4@gmail.com", "phone"=>"01222960009"}], "facility"=>"Benisuef university hospital"}], "centralContacts"=>[{"name"=>"Mariana AS Mansour, MD", "role"=>"CONTACT", "email"=>"mrmrsyk4@gmail.com", "phone"=>"01222960009", "phoneExt"=>"Benisuef"}], "overallOfficials"=>[{"name"=>"Mariana as Mansour, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"benisuef university hospital Egypt"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Beni-Suef University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"egypt benisuef", "investigatorFullName"=>"Mariana Soliman", "investigatorAffiliation"=>"Beni-Suef University"}}}}
