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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Cairo university hospitals, kasralainy

    Cairo, 11559

Other trials in Egypt

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 groups in NCT06127173
Study groupRoleWhat they receive
(group ZEEP)Active comparatorchildren will receive mask ventilation with PEEP level 0 cmH2O.
Receives: Other: Positive End Expiratory Pressure PEEP
(group PEEP 3)Experimentalchildren will receive mask ventilation with PEEP level 3 cmH2O.
Receives: Other: Positive End Expiratory Pressure PEEP
(group PEEP 5)Active comparatorchildren 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.

  1. Gastric residual volume immediately after intubation

    ultrasound guided measurement of gastric residual volume immediately after intubation

    Measured: 15 minutes

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted13 Nov 2023
  2. Study start10 Oct 2023
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

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)
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

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.

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