Comparing Different Startegies of Positive Pressure Ventilation in Children

NCT06612125 | Recruiting

• 1 other identifier: FMBSUREC/01092024/Mansour
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,

Conditions

Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (7)

• (PIP)

  peak inspiratory pressure

  within one hour

• Pplat

  plateau airway pressure

  within one hour

• (Cdyn)

  pulmonary dynamic compliance

  within one hour

• (RAW

  airway resistance

  within one hour

• VT

  exhaled tidal volume

  within one hour

• EtCO2

  end-expiratory carbon dioxide

  within one hour

• Vd/VT

  physiologic dead space over tidal volume

  within one hour

Secondary Outcomes (3)

• (MAP)

  within one hour

• (HR)

  within one hour

• postoperative respiratory adverse events

  within 24 hour

Study Arms (3)

vCV group

ACTIVE COMPARATOR

Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.

Other: volume controlled ventilation

PCV group

ACTIVE COMPARATOR

Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.

Other: pressure controlled ventilation

PCV-VG group

ACTIVE COMPARATOR

Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.

Other: pressure controlled volume grantanteed ventilation

Interventions

volume controlled ventilation OTHER

Pediatric patients in the VCV group (n= 30) received volume-controlled ventilation, target tidal volume was set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.

vCV group

pressure controlled ventilation OTHER

Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.

PCV group

pressure controlled volume grantanteed ventilation OTHER

Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.

PCV-VG group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age between 1 and 5 years.
• patient scheduled for laparoscopic inguinal hernia repair.
• American Society of Anesthesiologists classification of physical status of I-II.

You may not qualify if:

• cardiopulmonary disease.
• severe hepatorenal dysfunction.
• history of upper respiratory tract infection 2 weeks before the operation.
• overweight \[more than 20% of standard body weight\].
• neuromuscular disease.
• anticipated difficult airway.
• hiatus hernia or gastroesophageal reflux disease.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Benisuef university hospital

Benisuef, Egypt

RECRUITING

Study Officials

• Mariana as Mansour, MD

  benisuef university hospital Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana AS Mansour, MD

CONTACT

01222960009; mrmrsyk4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: egypt benisuef

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 30, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

EG (1)