Effect of PEEP on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children

NCT06127173 | Completed

• 1 other identifier: D 343
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anesthesia; Child

Keywords

ultrasound; gastric; residual; anesthesia; children

Outcome Measures

Primary Outcomes (1)

• Gastric residual volume immediately after intubation

  ultrasound guided measurement of gastric residual volume immediately after intubation

  15 minutes

Secondary Outcomes (2)

• Lung Ultrasound Score

  15 minutes

• Qualitative gastric antrum score

  15 minutes

Study Arms (3)

(group ZEEP)

ACTIVE COMPARATOR

children will receive mask ventilation with PEEP level 0 cmH2O.

Other: Positive End Expiratory Pressure PEEP

(group PEEP 3)

EXPERIMENTAL

children will receive mask ventilation with PEEP level 3 cmH2O.

Other: Positive End Expiratory Pressure PEEP

(group PEEP 5)

ACTIVE COMPARATOR

children will receive mask ventilation with PEEP level 3 cmH2O.

Other: Positive End Expiratory Pressure PEEP

Interventions

Positive End Expiratory Pressure PEEP OTHER

children will receive different levels of PEEP during induction of anesthesia

(group PEEP 3); (group PEEP 5); (group ZEEP)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Parental refusal Children with increased risk of regurgitation Known respiratory diseases or uncorrected congenital heart disease

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Fayoum University: collaborator

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Khaled Sarhan, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An attending anesthesiologist will unfold the envelopes 10min before starting the procedure. The children and the sonographer will be blinded to patient group allocation. The attending anesthesiologist will not be blinded; however, he will not participate in the ultrasonography or data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Asst. professor of anesthesia, Cairo university

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: October 10, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

EG (1)