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NCT Number: NCT06612125

Comparing Different Startegies of Positive Pressure Ventilation in Children

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,

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benisuef university hospital

Benisuef, Egypt

Location status: Recruiting

Location contact

Mariana As Mansour, MD

CONTACT

[email protected]

01222960009

About this study

The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. (PIP)

    Time frame: within one hour

    peak inspiratory pressure

  2. Pplat

    Time frame: within one hour

    plateau airway pressure

  3. (Cdyn)

    Time frame: within one hour

    pulmonary dynamic compliance

  4. (RAW

    Time frame: within one hour

    airway resistance

  5. VT

    Time frame: within one hour

    exhaled tidal volume

  6. EtCO2

    Time frame: within one hour

    end-expiratory carbon dioxide

  7. Vd/VT

    Time frame: within one hour

    physiologic dead space over tidal volume

Secondary outcomes

  1. (MAP)

    Time frame: within one hour

    mean arterial pressure

  2. (HR)

    Time frame: within one hour

    heart rate

  3. postoperative respiratory adverse events

    Time frame: within 24 hour

    cough, hoarseness, sore throat, hypoxemia, laryngospasm, bronchospasm.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana AS Mansour, MD

CONTACT

[email protected]

01222960009 ext. Benisuef

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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