Clinical Trials in Brazil / NCT02440919
Active, not recruiting Not applicable

Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)

NCT02440919 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2013-06
Last updated
2022-08-15

Condition(s) studied

HypoventilationHypoxemia

Investigational drug(s) / intervention(s)

Hyperoxygenation 100% FiO2Hyperoxygenation 20% FiO2Hyperinflation (PEEP- ZEEP) Basal FiO2Hyperinflation (PEEP- ZEEP) 20% FiO2

Hyperoxygenation 100% FiO2: Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.

Hyperoxygenation 20% FiO2: Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

Hyperinflation (PEEP- ZEEP) Basal FiO2: Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient.

Hyperinflation (PEEP- ZEEP) 20% FiO2: Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen.

Study summary

This is a double crossover study where all patients are randomly allocated to one of two treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two suctioning methods for each patient: one involving hyperoxygenation with administration of 100% oxygen 1 minute before and after suction (intervention I), and the other hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same way.The second treatment (B) uses a technique of hyperinflation with the mechanical ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen supply in the same way.

All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on Day 1. Patients received two treatments, at least four hours apart. The first treatment is in the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of the treatments was reversed using the same patient position sequence.The interventions I and II are performed at least 4 hours apart to minimize any carryover effect.

Eligibility

Sex
ALL
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
Inclusion Criteria: * Mechanical ventilation for more than 12h * Hemodynamic stability * Presence of indication criteria of endotracheal aspiration procedure Exclusion Criteria: * High doses of vasopressor amines amines and/or severe arrhythmias * Hemoglobin \< 7 g/dL * FiO2 ≥ 0.6 * PEEP ≥ 10 cmH2O * Conditions: rib fractures, chest drain, severe bronchospasm, pneumothorax not drained and tracheostomy * Contraindications of ventilator hyperinflation(PEEP-ZEEP): intracranial pressure \> 10 mmHg, bleeding disorders, accented degrees of gastroesophageal reflux and bullous lung disease.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The ICU of Hospital Santa Casa de Misericordia of Batatais Batatais São Paulo

More Universidade Federal de Sao Carlos trials in Brazil

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02440919 on ClinicalTrials.gov ↗ ← All trials in Brazil