- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06127173
Effect of PEEP on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children
Effect of Positive End Expiratory Pressure on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children Undergoing Elective Surgery: A Prospective Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized into three groups:
- Group (ZEEP) with PEEP level 0 cmH2O.
- Group (PEEP 3) with PEEP level 3 cmH2O.
- Group (PEEP 5) with PEEP level 5 cmH2O. The principal investigator will create a computer-generated random table for randomization and allocation which will be numbered in sequence and will be sealed in envelopes. An attending anesthesiologist will unfold the envelopes 10min before starting the procedure. The parents and a sonographer will be blinded to patient group allocation. The attending anesthesiologist will not be blinded; however, the attending anesthesiologist will not participate in the ultrasonography or data analysis.
Anesthetic technique:
All children will undergo routine preoperative investigations: Complete blood count and coagulation profile. First, children will enter the recovery room for examination as regards the fulfillment of inclusion criteria to be in the study or to be excluded from the study. Second, the children will be included in the study will be premedicated using midazolam 0.5 mg/kg IM and IM atropine 0.2 mg /kg. Then a baseline antral area for each child lying supine will be measured by a single anesthesiologist using GE, LOGIC-e Ultrasound device with a 4-8 MHz transducer. The gastric antrum will be obtained in the sagittal or parasagittal plane between the left lobe of the liver and the pancreas, at the level of the aorta or inferior vena cava. The transducer will be tilted and rotated perpendicular to the long axis of the antrum, after having the longitudinal (D1) and anteroposterior (D2) diameters of the gastric antrum, the cross sectional areal, (CSA) will be calculated as follows:
CSA = D1x D2 x p/4 Gastric volume will be obtained by a formula based on a study by perlas.15 Stomach volume (mL) = (27 + 14.6 CSA (cm2)) - (1.28*age (years)). After that, the lungs will be divided into three regions: anterior, lateral and posterior, using the anterior and posterior axillary lines as boundaries. The ultrasound transducer will be placed perpendicular or parallel to the rib cage, and each region of the lung will be scanned bilaterally. The ultrasound probe will be first placed perpendicular to the rib cage to look for pulmonary atelectasis, and then the ultrasound probe will be placed parallel to the rib cage to take images at the most obvious point of pulmornary atelectasis. The scoring criteria will be Pulmonary consolidation score (zero- no consolidation; 1-minimal parietal consolidation; 2-small consolidation; 3-large consolidation). Pulmonary atelectasis will be defined as a pulmonary consolidation score ≥2 in any region.
Upon arrival to the operation room, standard monitors (5-lead electrocardiogram, pulse oximetry, noninvasive blood pressure monitoring, capnography) will be applied and continued all over the operation.
Intravenous cannula will be introduced after induction of anesthesia by inhalational induction with a facemask using sevoflurane 8% and oxygen 50% for all children. Then, all children will have 2-3mg /Kg of propofol, 1mcg/Kg of fentanyl and 0.4-0.6 mg /kg of rocronium. Face mask ventilation with pressure controlled ventilation using PIP 12cmH2O 16, a PEEP level according to randomization done before will be applied for 90s to all children and respiratory rate (RR) will be adjusted according to the rule, RR=24-age/2. Then, an appropriate sized endotracheal tube will be introduced. Anesthesia will be maintained using Isoflorane 1% MAC with the same parameters of mechanical ventilation during induction of anesthesia. Immediately after intubation, another measurement for gastric volume will be taken ultrasound guided as described before. Ringer Lactate solution will be infused according to the rule 4-2-1 till the end of surgery. Before awakening of the patient another measurement for pulmonary consolidation score will be taken. Then, they will be awakened as usual at the end of surgery and transferred to post anesthesia care unit (PACU).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khaled Sarhan, MD
- Phone Number: +201020067816
- Email: khaled.sarhan@kasralainy.edu.eg
Study Contact Backup
- Name: Safaa Ragab, MD
- Phone Number: +201004631943
- Email: sgr00@fayoum.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11559
- Recruiting
- Cairo university hospitals, kasralainy
-
Contact:
- Khaled Sarhan, MD
- Phone Number: +201020067816
- Email: khaled.sarhan@kasralainy.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children aged1 to 12 years old American Society of Anesthesiologists (ASA) physical status I or II Children will be scheduled for elective surgery under general anesthesia.
Exclusion Criteria:
Parental refusal Children with increased risk of regurgitation Known respiratory diseases or uncorrected congenital heart disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: (group ZEEP)
children will receive mask ventilation with PEEP level 0 cmH2O.
|
children will receive different levels of PEEP during induction of anesthesia
|
Experimental: (group PEEP 3)
children will receive mask ventilation with PEEP level 3 cmH2O.
|
children will receive different levels of PEEP during induction of anesthesia
|
Active Comparator: (group PEEP 5)
children will receive mask ventilation with PEEP level 3 cmH2O.
|
children will receive different levels of PEEP during induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric residual volume immediately after intubation
Time Frame: 15 minutes
|
ultrasound guided measurement of gastric residual volume immediately after intubation
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Ultrasound Score
Time Frame: 15 minutes
|
Each lung will be divided into 3 areas.
For each area, a score of 0 to 3 has been assigned.
Scores as follows, for any lung area: 0 indicates A-pattern (defined by the presence of only A-lines); 1, B-pattern (defined as the presence of 3 B-lines, well-spaced); 2, severe B-pattern (defined as the presence of crowded and coalescent B lines with or without consolidations limited to subpleural space); and 3, extended consolidation.
|
15 minutes
|
Qualitative gastric antrum score
Time Frame: 15 minutes
|
|
15 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Khaled Sarhan, MD, Cairo University Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D 343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
Boston Medical CenterCenter for the Study of Social PolicyCompletedChild Abuse | Parenting | Child Development | Child Rearing | Child NeglectUnited States
-
Oral Health Centre of Expertise in Western NorwayOral Health Center of Expertise Rogaland, Norway; Childrens advocacy center... and other collaboratorsRecruitingChild Abuse | Child Neglect | Child MaltreatmentNorway
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
University of South CarolinaCompletedParents | Child Behavior | Child Health | Child, PreschoolUnited States
-
Milton S. Hershey Medical CenterRecruitingChild Abuse | Child Neglect | Child MaltreatmentUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingParent-Child Relations | Parenting | Child Behavior | Child MaltreatmentUnited States
-
Boston Medical CenterValhalla Foundation; Centering Healthcare Institute; Overdeck Family foundationRecruitingParent-Child Relations | Parenting | Child Behavior | Child DevelopmentUnited States
-
South London and Maudsley NHS Foundation TrustCarol Hardy, Research Lead, South London and Maudsley NHS FoundationCompletedChild Development | Parent Child Relationships | Parent Child InteractionsUnited Kingdom
Clinical Trials on Positive End Expiratory Pressure PEEP
-
Bozyaka Training and Research HospitalRecruitingRegional Cerebral Oxygen SaturationTurkey
-
Children's Hospital of PhiladelphiaChristiana Care Health ServicesTerminatedInfant, Premature, Diseases | Respiratory Insufficiency Syndrome of NewbornUnited States
-
Brugmann University HospitalCompleted
-
Seoul National University HospitalUnknown
-
Murdoch Childrens Research InstituteUniversity of Pennsylvania; University of Oxford; Academisch Medisch Centrum...RecruitingPreterm Birth | Lung InjuryUnited States, Australia, Austria, Italy, Netherlands, United Kingdom, Poland, France
-
Johannes Gutenberg University MainzCompletedRespiratory InsufficiencyGermany
-
Capital Medical UniversityCompleted
-
Tanta UniversityRecruitingLaparoscopic Bariatric Surgery | Postoperative Atelectasis | Positive End-expiratory Pressure | Hemodynamic VariableEgypt
-
Massachusetts General HospitalUnknown
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingVentilator-Induced Lung Injury | Sepsis Syndrome | Mechanical Ventilation ComplicationUnited States