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Current Practice of Ventilation Strategies in Children undergoing General Anesthesia and Associations with Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study

Current Practice of Ventilation Strategies in Children undergoing General Anesthesia and Associations with Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study - BIG APPLE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/102880
Enrollment
10000
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z419- Encounter for procedure for purposes other than remedying health state, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

David van Meenen MD PhD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Those undergoing general anesthesia airway management with tube or Laryngeal mask airway and connected to mechanical ventilator.

Exclusion criteria

Exclusion criteria: patients undergoing surgical procedures involving extra-corporal circulation; patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation; sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and (rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.

Design outcomes

Primary

MeasureTime frame
The main study endpoint is incidence of postoperative pulmonary complications (PPCs) in the first five postoperative days.Timepoint: Collected after induction: Type of airway management: intubation or tracheostomy (invasive); supraglottic airway device; size of tube or supraglottic airway device. Collected 15 minutes after incision: Ventilator settings: including but not restricted to: adult / pediatric / neonatal breathing circuit; minimization of deadspace: ventilation mode, expiratory tidal volume (VTe) or inspiratory tidal volume (VTi) (only in case VTe is not available); PEEP; PIP or Pplat; level of pressure support above PEEP (only in spontaneously breathing patients); FiO2 (%); set and measured RR; I:E ratio; or inspiration time; SpO2; EtCO2; fresh gas flow; use of active humidification; Mean arterial pressure (invasive or non-invasive (MAP mmHg); heart rate (HR in bpm).

Secondary

MeasureTime frame
Secondary parameters are type of airway management Tid ventilation settings and parameters including tidal volume peak inspiratory pressure plateau pressure (positive end-expiratory pressure fraction of inspired oxygen inspiration to expiration ratio inspiration time set and total respiratory rate compliance driving pressure and the mechanical power of ventilation Clinical outcome measures: Saturation of peripheral oxygen and end-tidal carbon dioxide intraoperative complications hospital length of stay and ICU admittance Timepoint: Collected after induction Collected 15 minutes after incision Collected during the duration of the procedure

Countries

Australia, Austria, Bolivia, Brazil, Croatia, Denmark, Germany, Greece, India, Indonesia, Italy, Malaysia, Morocco, Portugal, Serbia, Spain, Sudan, Suriname, Sweden, Switzerland, Turkey, United Arab Emirates

Contacts

Public ContactRaksha Kundal

AIMS JAMMU

raksha.kundal@aiimsjammu.edu.in9910939123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026