Overview

This trial is active, not recruiting.

Conditions hypoventilation, hypoxemia
Treatments hyperoxygenation 100% fio2, hyperoxygenation 20% fio2, hyperinflation (peep- zeep) basal fio2, hyperinflation (peep- zeep) 20% fio2
Sponsor Universidade Federal de Sao Carlos
Start date June 2013
End date January 2015
Trial size 78 participants
Trial identifier NCT02440919, 11354813.1.0000.5504

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2).
hyperoxygenation 20% fio2
Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
(Other)
Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
hyperoxygenation 100% fio2
Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.
(Other)
Ventilator hyperinflation, with 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.
(Other)
Ventilator hyperinflation and hyperoxygenation involved supplying 20% 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.

Primary Outcomes

Measure
Oxygen (SpO2) and Ventilation (ETCO2) measures
time frame: Endotracheal suctioning is carried out according each protocol. Oxygen (SpO2) and ventilation (ETCO2) measures are performed before and after supply oxygen given for 1 minute, 60 seconds after each suctioning, immediately after and 30 minutes the end.

Secondary Outcomes

Measure
Respiratory mechanic measures
time frame: Endotracheal suctioning is carried out according each protocol. Baseline Respiratory mechanic measures are performed before suctioning, immediately after and 30 minutes the end.
Volumetric capnography measures
time frame: Endotracheal suctioning is carried out according each protocol. Baseline Volumetric capnography measures are performed before suctioning, immediately after and 30 minutes the end.

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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.

Additional Information

Official title Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
Principal investigator Jacqueline RF Vianna, Master
Description Endotracheal suction must be carried out only through precise indication, because it is associated with undesirable effects on the hemodynamic parameters, ventilation, oxygenation and respiratory mechanics. The hyperoxygenation is one of the methods of prevention of hypoxemia induced by tracheal suction procedure and have been proposed for its efficiency. Another method is the hyperinflation with the mechanical ventilator. Ventilator hyperinflation improves oxygenation, mobilizes the bronchial secretion excess and re-expand the lung collapsed areas. The PEEP-ZEEP is a ventilator hyperinflation technique, described as a lung inflation through a positive pressure enhancement at the end of expiration (PEEP), followed by rapid lung deflation with an abrupt reduction in the PEEP to ZEEP (0 centimeters of water (cmH2O)).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidade Federal de Sao Carlos.