High-Frequency Oscillatory Ventilation Associated With Inhaled Nitric Oxide in Children

NCT00924846 | Completed Phase 3

• 1 other identifier: upeclin/HC/FMB-Unesp-26
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background/Objectives: Acute hypoxemic respiratory failure (AHRF) is a frequent cause of pediatric ICU admission. Early treatment with inhaled nitric oxide (iNO) plus conventional mechanical ventilation (CMV) improves oxygenation, responsiveness being significantly influenced by alveolar recruitment level. High-frequency oscillatory ventilation (HFV) is conceptually very attractive as constant mean airway pressure optimizes lung recruitment; this could maximize iNO effects. Aims: To analyze the effects of HFV on oxygenation indexes in AHRF children under CMV and iNO. Methods: Children with AHRF (oxygenation index ≥10) aged between one month and 14 years under CMV with PEEP≥10cmH2O and 5ppm iNO for 1h were randomly assigned to CMV (CMVG, n=12) or HFV (HFVG, n=12) in a crossover design. Children with chronic cardiac or pulmonary diseases were excluded. Patients were kept under one of the two ventilation modes for 8h, crossing to the other for 8h, and then back again to complete 24h observation. Blood gas analysis, oxygenation indexes, and hemodynamic variables were recorded at enrollment (Tind), 1h after iNO start and then every 4h (T4h etc). The Mann-Whitney U test compared group ages and PRISM scores, and the Fisher test genders. Moments and groups were compared by repeated measure analysis for independent groups. Significance was considered at p\<0.05.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

high frequency oscillatory ventilation; respiratory failure; children; inhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

• Oxygenation indexes

  2 years

Study Arms (2)

HFOV plus iNO

ACTIVE COMPARATOR

HFOV plus iNO: high frequency oscillatory ventilation plus inhaled nitric oxide

Procedure: High frequency oscillatory ventilation

CMV plus iNO

ACTIVE COMPARATOR

CMV (conventional mechanical ventilation) iNO (inhaled nitric oxide)

Procedure: High frequency oscillatory ventilation

Interventions

High frequency oscillatory ventilation PROCEDURE

Mechanical ventilation as high frequency oscillatory ventilation for 8h periods

Also known as: HFOV

CMV plus iNO; HFOV plus iNO

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with AHRF (oxygenation index ≥ 10) aged between one month and 14 years under CMV with PEEP ≥ 10 cmH2O and 5 ppm iNO for 1 hour.

You may not qualify if:

• Children with chronic cardiac or pulmonary diseases.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

UNESP-Botucatu Medical School

Botucatu, São Paulo, 18.618-970, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jose R Fioretto, MD, PhD

  UNESP-Botucatu Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: April 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2009
• Last Updated: June 22, 2009

Record last verified: 2009-06

Locations

BR (1)