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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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)).

Conditions

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Hypoventilation Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyperoxygenation - 100% FiO2

Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2).

Group Type OTHER

Hyperoxygenation 20% FiO2

Intervention Type OTHER

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

Hyperoxygenation - 20% FiO2

Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

Group Type OTHER

Hyperoxygenation 100% FiO2

Intervention Type OTHER

Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.

Hyperinflation - Basal FiO2

Ventilator hyperinflation, with keeping the oxygen already offered to the patient.

Group Type OTHER

Hyperinflation (PEEP- ZEEP) 20% FiO2

Intervention Type OTHER

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

Hyperinflation - 20% FiO2

Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen.

Group Type OTHER

Hyperoxygenation 20% FiO2

Intervention Type OTHER

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

Hyperinflation (PEEP- ZEEP) Basal FiO2

Intervention Type OTHER

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

Interventions

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Hyperoxygenation 100% FiO2

Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.

Intervention Type OTHER

Hyperoxygenation 20% FiO2

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

Intervention Type OTHER

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.

Intervention Type OTHER

Hyperinflation (PEEP- ZEEP) 20% FiO2

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No