Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440919
Recruitment Status : Unknown
Verified May 2016 by Jacqueline R F Vianna, Universidade Federal de Sao Carlos.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Jacqueline R F Vianna, Universidade Federal de Sao Carlos

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Hypoventilation Hypoxemia Other: Hyperoxygenation 100% FiO2 Other: Hyperoxygenation 20% FiO2 Other: Hyperinflation (PEEP- ZEEP) Basal FiO2 Other: Hyperinflation (PEEP- ZEEP) 20% FiO2 Not Applicable

Detailed 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)).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
Study Start Date : June 2013
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Hyperoxygenation - 100% FiO2
Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2).
 Other: Hyperoxygenation 20% FiO2
Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
Hyperoxygenation - 20% FiO2
Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
 Other: Hyperoxygenation 100% FiO2
Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.
Hyperinflation - Basal FiO2
Ventilator hyperinflation, with keeping the oxygen already offered to the patient.
 Other: Hyperinflation (PEEP- ZEEP) 20% FiO2
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.
 Other: Hyperoxygenation 20% FiO2
Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. ]
    Oxygenation is evaluated by peripheral oxygen saturation (SpO2), measured by a respiratory monitor (DX-2021™ or DX-2023™- Dixtal™. The Impact on oxygenation was detecting hypoxemia with SpO2 values below 90%. Ventilation is evaluated by end-tidal carbon dioxide measured by carbon dioxide sensor (CAPNOSTAT CO2 Sensor, Novametrix Medical Systems Inc.) inserted into the mechanical ventilator circuit Dixtal 3012™ - Dixtal™. The impact on ventilation was detecting hypoventilation with values exceeding 50 mmHg.


Secondary Outcome Measures :
  1. 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. ]
    Respiratory mechanics was measured by mechanical ventilator Dixtal 3012™- Dixtal™. Its impact will be evaluated by the changes of parameters of normality of variables: auto-PEEP, dynamics compliance (Cd), static compliance (Cst), airway resistance (rva), Airway occlusion pressure (P0.1), slow vital capacity (SVC) and maximal inspiratory pressure (MIP).

  2. 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. ]
    Volumetric capnography was evaluated by carbon dioxide sensor (CAPNOSTAT CO2™ Sensor, Novametrix Medical Systems Inc.) measured by mechanical ventilator Dixtal 3012™- Dixtal™. Its impact will be evaluated by the changes of parameters of normality of variables: ETCO2, anatomical dead space/tidal volume ratio (Vd/VT), alveolar dead space (Vd), alveolar ventilation (Va), maximal tidal elimination of carbon dioxide (VtCO2), carbon dioxide production (VCO2) and partial pressure of expired (PeCO2).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440919


Locations
Layout table for location information
Brazil
The ICU of Hospital Santa Casa de Misericordia of Batatais
Batatais, São Paulo, Brazil, 14300-000
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
Layout table for investigator information
Principal Investigator: Jacqueline RF Vianna, Master UFSCar
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jacqueline R F Vianna, Master's degree, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT02440919    
Other Study ID Numbers: 11354813.1.0000.5504
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jacqueline R F Vianna, Universidade Federal de Sao Carlos:
Respiratory mechanics
Oxygenation
Suction
Mechanical ventilation
 Respiratory therapy
Capnography
Pulmonary Ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoventilation
Hypoxia
Signs and Symptoms, Respiratory
 Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases