AnesthesiaNCT06127173
Effect of PEEP on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children
A study testing Positive End Expiratory Pressure PEEP in people with Anesthesia and Child, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Anesthesia, Child
- What is being tested?
- Positive End Expiratory Pressure PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Parental refusal Children with increased risk of regurgitation Known respiratory diseases or uncorrected congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery
Read the 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).
- Conditions
- Anesthesia, Child
- Being tested
- Positive End Expiratory Pressure PEEP
- Keywords
- ultrasound, gastric, residual, anesthesia, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive End Expiratory Pressure PEEPOther
children will receive different levels of PEEP during induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| (group ZEEP) | Active comparator | children will receive mask ventilation with PEEP level 0 cmH2O. Receives: Other: Positive End Expiratory Pressure PEEP |
| (group PEEP 3) | Experimental | children will receive mask ventilation with PEEP level 3 cmH2O. Receives: Other: Positive End Expiratory Pressure PEEP |
| (group PEEP 5) | Active comparator | children will receive mask ventilation with PEEP level 3 cmH2O. Receives: Other: Positive End Expiratory Pressure PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume immediately after intubation
ultrasound guided measurement of gastric residual volume immediately after intubation
Measured: 15 minutes
Secondary outcomes (2)
Lung Ultrasound Score
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.
Measured: 15 minutes
Qualitative gastric antrum score
- Grade 0 antrum: is defined as the absence of fluid content in both supine and RLD positions.
- Grade 1 antrum: If fluid content is observed only in the RLD position, but not in the supine position.
- Grade 2 antrum: If fluid is observed in both supine and RLD.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start10 Oct 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127173
- Sponsor's protocol ID
- D 343
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06127173
- Acronym / sponsor ID
- D 343
- Conditions
- Anesthesia, Child
- Keywords
- ultrasound, gastric, residual, anesthesia, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Fayoum University
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| (group ZEEP) | Active comparator | Other: Positive End Expiratory Pressure PEEPchildren will receive mask ventilation with PEEP level 0 cmH2O. |
| (group PEEP 3) | Experimental | Other: Positive End Expiratory Pressure PEEPchildren will receive mask ventilation with PEEP level 3 cmH2O. |
| (group PEEP 5) | Active comparator | Other: Positive End Expiratory Pressure PEEPchildren will receive mask ventilation with PEEP level 3 cmH2O. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Parental refusal Children with increased risk of regurgitation Known respiratory diseases or uncorrected congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive End Expiratory Pressure PEEPchildren will receive different levels of PEEP during induction of anesthesia | Other | (group PEEP 3), (group PEEP 5), (group ZEEP) |
Primary outcome
Gastric residual volume immediately after intubation
Time frame: 15 minutes
ultrasound guided measurement of gastric residual volume immediately after intubation
2 secondary outcomes
Lung Ultrasound Score
Time frame: 15 minutes
Qualitative gastric antrum score
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Sarhan, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive End Expiratory Pressure PEEP in people with Anesthesia and Child, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric residual volume immediately after intubation (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.