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

Primary Purpose

Hypoventilation, Hypoxemia

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyperoxygenation 100% FiO2
Hyperoxygenation 20% FiO2
Hyperinflation (PEEP- ZEEP) Basal FiO2
Hyperinflation (PEEP- ZEEP) 20% FiO2
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoventilation focused on measuring Respiratory mechanics, Oxygenation, Suction, Mechanical ventilation, Respiratory therapy, Capnography, Pulmonary Ventilation

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The ICU of Hospital Santa Casa de Misericordia of Batatais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Hyperoxygenation - 100% FiO2

Hyperoxygenation - 20% FiO2

Hyperinflation - Basal FiO2

Hyperinflation - 20% FiO2

Arm Description

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

Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.

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

Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen.

Outcomes

Primary Outcome Measures

Oxygen (SpO2) and Ventilation (ETCO2) measures
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

Respiratory mechanic measures
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).
Volumetric capnography measures
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).

Full Information

First Posted
March 3, 2015
Last Updated
August 12, 2022
Sponsor
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02440919
Brief Title
Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)
Acronym
OSVHES
Official Title
Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoventilation, Hypoxemia
Keywords
Respiratory mechanics, Oxygenation, Suction, Mechanical ventilation, Respiratory therapy, Capnography, Pulmonary Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperoxygenation - 100% FiO2
Arm Type
Other
Arm Description
Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2).
Arm Title
Hyperoxygenation - 20% FiO2
Arm Type
Other
Arm Description
Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
Arm Title
Hyperinflation - Basal FiO2
Arm Type
Other
Arm Description
Ventilator hyperinflation, with keeping the oxygen already offered to the patient.
Arm Title
Hyperinflation - 20% FiO2
Arm Type
Other
Arm Description
Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen.
Intervention Type
Other
Intervention Name(s)
Hyperoxygenation 100% FiO2
Intervention Description
Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.
Intervention Type
Other
Intervention Name(s)
Hyperoxygenation 20% FiO2
Intervention Description
Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
Intervention Type
Other
Intervention Name(s)
Hyperinflation (PEEP- ZEEP) Basal FiO2
Intervention Description
Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient.
Intervention Type
Other
Intervention Name(s)
Hyperinflation (PEEP- ZEEP) 20% FiO2
Intervention Description
Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen.
Primary Outcome Measure Information:
Title
Oxygen (SpO2) and Ventilation (ETCO2) measures
Description
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.
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 Outcome Measure Information:
Title
Respiratory mechanic measures
Description
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).
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.
Title
Volumetric capnography measures
Description
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).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline RF Vianna, Master
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
Facility Information:
Facility Name
The ICU of Hospital Santa Casa de Misericordia of Batatais
City
Batatais
State/Province
São Paulo
ZIP/Postal Code
14300-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2912927
Citation
Rogge JA, Bunde L, Baun MM. Effectiveness of oxygen concentrations of less than 100% before and after endotracheal suction in patients with chronic obstructive pulmonary disease. Heart Lung. 1989 Jan;18(1):64-71.
Results Reference
background
PubMed Identifier
12109234
Citation
Berney S, Denehy L. A comparison of the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients. Physiother Res Int. 2002;7(2):100-8. doi: 10.1002/pri.246.
Results Reference
background
PubMed Identifier
21914178
Citation
Herbst-Rodrigues MV, Carvalho VO, Auler JO Jr, Feltrim MI. PEEP-ZEEP technique: cardiorespiratory repercussions in mechanically ventilated patients submitted to a coronary artery bypass graft surgery. J Cardiothorac Surg. 2011 Sep 13;6:108. doi: 10.1186/1749-8090-6-108.
Results Reference
background
PubMed Identifier
32636279
Citation
de Freitas Vianna JR, Pires Di Lorenzo VA, Lourenco da S Simoes MM, Guerra JL, Jamami M. Effects of Zero PEEP and < 1.0 FIO2 on SpO2 and PETCO2 During Open Endotracheal Suctioning. Respir Care. 2020 Dec;65(12):1805-1814. doi: 10.4187/respcare.07435. Epub 2020 Jul 7.
Results Reference
derived
PubMed Identifier
28003557
Citation
Vianna JR, Pires Di Lorenzo VA, Simoes MM, Jamami M. Comparing the Effects of Two Different Levels of Hyperoxygenation on Gas Exchange During Open Endotracheal Suctioning: A Randomized Crossover Study. Respir Care. 2017 Jan;62(1):92-101. doi: 10.4187/respcare.04665. Epub 2016 Nov 15.
Results Reference
derived

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

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