Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT03069157
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization will be done by computer generated numbers and concealed by serially numbered,opague and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lung aeration score 5minutes following induction of general anesthesia', 'timeFrame': 'Lung ultrasound examinations will be performed 5minutes following induction of general anesthesia', 'description': 'Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0'}], 'secondaryOutcomes': [{'measure': '•The sum of surface area of atelectatic regions', 'timeFrame': 'It will be measured at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia,5 min before extubation and 5 min after extubation at recovery room to detect and monitor atelectasis', 'description': 'The sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia Induced Atelectasis']}, 'descriptionModule': {'briefSummary': 'Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.\n\nThe aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound.\n\nObjectives\n\n* To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound.\n* To Estimate the change of Pao2 with anesthesia induced lung atelectasis.\n* To Estimate the change of Pao2 with lung recruitment.\n* To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.', 'detailedDescription': 'This a randomized control trial is designed to include 40 children aged from one to four years presented for major abdominal surgery.\n\nForty patients meeting the inclusion criteria will be randomly assigned into to two equal groups:\n\nGroup C (n= 20): Without recruitment maneuver (control group)\n\nGroup REC (n= 20): recruitment group\n\nAll children will be premedicated with oral midazolam 0.5mg/kg half hour before procedure and atropine at a dose of 0.01-0.02 mg/kg( IM). Continuous electrocardiogram (ECG) , pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring will be applied and all patients will be induced with inhalational anesthetic using Sevoflurane+ oxygen(O2) with mac 2%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 2μg/kg, muscle relaxant will be given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube.\n\nAfter induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5, and Fio2 1, baseline arterial blood gas will be withdrawn. Patients will be divided into two groups. Group (REC) recruitment group; in this group, lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O22,23. In next assessment time, if still there are atelectatic areas recruitment will be repeated and patient will be maintained at PEEP 10 cm H2O till the end of surgery. In group (C) non recruitment group, patient ventilation will be maintained on aforementioned tidal volume without recruitment but with PEEP 5cm H2O.\n\nLung ultrasound (LUS) LUS will be performed with the portable echograph MicroMax (SonoSite, M-turbo) using a linear probe of 3 to 6 MHz. Each hemithorax will be divided into six sections using three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines, one above the diaphragm and another one 1 cm above the nipples.\n\nAs LUS provides regional information, we will repeat the following examination sequence in each hemithorax and in all patients: (1) anterior, (2) lateral, and (3) posterior regions starting from the diaphragm (caudal lung) and moving toward the apex (cranial lung).13,14 Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .24 (fig. 1).The LUS of a normal lung shows a lung sliding (caused by the respiratory movement of the visceral pleura relative to the fixed parietal pleura) and A lines (repetitive horizontal reverberation artifacts generated by air within the lungs separated by regular intervals, the distances of which being equal that between the skin and the pleural line.\n\nPatients demographic data will be collected; age, gender, weight, height, type of surgery and duration of surgery.\n\nLung ultrasound examinations will be performed at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia, before extubation and after extubation at recovery room to detect and monitor atelectasis. Arterial blood samples will be collected simultaneously to measure Pao2.\n\nAtelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0.\n\nThe sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded.\n\nOther data as heart rate, systolic, diastolic and mean arterial blood pressure will be recorded at same measuring points and during recruitment.\n\nAssessment for incidence of pneumothorax and postoperative pulmonary complications like; postoperative lung collapse and postoperative pneumonia.\n\nAssessment the duration of postoperative hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ASA physical status I-II.\n2. Age (1-4) years.\n3. Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,).\n\nExclusion Criteria:\n\n1. Parents' refusal.\n2. Patients with congenital heart disease.\n3. Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)\n4. Patients with respiratory tract infection.\n5. Patients with chest wall deformities"}, 'identificationModule': {'nctId': 'NCT03069157', 'briefTitle': 'Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound in Children Undergoing Major Abdominal Surgery.', 'orgStudyIdInfo': {'id': 'N-33-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Without lung recruitment maneuver', 'description': 'patient ventilation will be maintained After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5 without recruitment but with PEEP 5cm H2O.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'recruitment group', 'description': 'lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O.', 'interventionNames': ['Procedure: lung recruitment maneuver']}], 'interventions': [{'name': 'lung recruitment maneuver', 'type': 'PROCEDURE', 'description': 'lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O', 'armGroupLabels': ['recruitment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '202', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Iman R Abdel- Aal, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesthesia department , Cairo university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Anesthesia and surgical icu, Principal Investigator, Assistant lecturer', 'investigatorFullName': 'Ahmed nabih youssef', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}