Risk Factors of Extubation Failure in PICU Patients

NCT06557941 | Recruiting

• 1 other identifier: Soh-Med-24-07-11MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 20% of MV patients experience EF \[10\]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death \[10, 11\] .

Conditions

Extubation Failure

Keywords

extubation failure; mechanical ventilation; PICU

Outcome Measures

Primary Outcomes (2)

• successful extubation and weaning from mechanical ventilation

  passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

  48 hours

• failed extubation , failed weaning from mechanical ventilation

  not passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

  48 hours

Secondary Outcomes (1)

• survival or death

  30 days

Study Arms (2)

A:successful extubation

mechanically ventilated PICU patients who pass spontaneous breathing trial and air leak test , extubated and not requiring to be re-intubated within 48 hours.

B: failed extubation

mechanically ventilated PICU patients who don't pass spontaneous breathing trial and air leak test , extubated and requiring to be re-intubated within 48 hours.

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients in PICUS in Sohag University Hospitals.

You may qualify if:

• All patient at PICU \< 18 years subjected to MV through an endotracheal tube at least \>12 hours.
• Patients eligible for weaning from MV according to the weaning criteria (Evidence for some reversal of the underlying cause following for respiratory failure, Adequate oxygenation" PaO2/FIO2 ratio ≥ 200, FIO2 ≤ 0.40, PaO2 ≥ 60, PaCO2 ≤ 60 and PEEP ≤ 5 cmH2O.", PH ≥ 7.25, Respiratory rate (RR) ≤ 45 bpm, Heart rate (HR) ≤ 140 bpm,(rapid shallow breathing index = tidal volume / RR) RSBI ≤ 8 breaths/min/ml/kg body weight, Hemodynamic stable, no or minimal vasopressor or inotropes"\[1,12\],.
• Appropriate level of consciousness, No continuous sedation infusion nor neuromuscular blocking agents, afebrile, adequate hemoglobin ≥ 7.5 g/dl and/or no evidence of hemorrhage.

You may not qualify if:

• Patients less than 30 days.
• Tracheostomized patients.
• Death on mv ≤ 12 hours.
• Unplanned extubation.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

RECRUITING

Biospecimen

Retention: NONE RETAINED

Patients will be divided into 2 groups : group A : successful extubation. group B : failed extubation

Study Officials

• Mostafa Ashry Mohamed, assistant professeer

  pediatrics department faculty of medicine sohag university

  STUDY DIRECTOR

• Rania Gamal Mostafa Abdelatif, lecturer

  pediatrics department faculty of medicine sohag university

  STUDY DIRECTOR

Central Study Contacts

mariam raafat helmy, postgraduate

CONTACT

01284134530; mariam.rafaat@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate pediatriacian

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

EG (1)