HypoventilationOSVHESNCT02440919
Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)
A study testing Hyperoxygenation 100% FiO2, Hyperoxygenation 20% FiO2 and Hyperinflation (PEEP- ZEEP) Basal FiO2 in people with Hypoventilation and Hypoxemia, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hypoventilation, Hypoxemia
- What is being tested?
- Hyperoxygenation 100% FiO2, Hyperoxygenation 20% FiO2 and Hyperinflation (PEEP- ZEEP) Basal FiO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation for more than 12h
- Hemodynamic stability
- Presence of indication criteria of endotracheal aspiration procedure
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
The ICU of Hospital Santa Casa de Misericordia of Batatais
Batatais, São Paulo, 14300-000
About this study
Official title: Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
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.
Read the 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)).
- Conditions
- Hypoventilation, Hypoxemia
- Being tested
- Hyperoxygenation 100% FiO2, Hyperoxygenation 20% FiO2, Hyperinflation (PEEP- ZEEP) Basal FiO2, Hyperinflation (PEEP- ZEEP) 20% FiO2
- Keywords
- Respiratory mechanics, Oxygenation, Suction, Mechanical ventilation, Respiratory therapy, Capnography, Pulmonary Ventilation
- Medical subject headings
- Hypoventilation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperoxygenation 100% FiO2Other
Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.
Hyperoxygenation 20% FiO2Other
Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
Hyperinflation (PEEP- ZEEP) Basal FiO2Other
Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient.
Hyperinflation (PEEP- ZEEP) 20% FiO2Other
Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxygenation - 100% FiO2 | Other | Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2). Receives: Other: Hyperoxygenation 20% FiO2 |
| Hyperoxygenation - 20% FiO2 | Other | Hyperoxygenation involved supplying 20% oxygen above FiO2 basal. Receives: Other: Hyperoxygenation 100% FiO2 |
| Hyperinflation - Basal FiO2 | Other | Ventilator hyperinflation, with keeping the oxygen already offered to the patient. Receives: Other: Hyperinflation (PEEP- ZEEP) 20% FiO2 |
| Hyperinflation - 20% FiO2 | Other | Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen. Receives: Other: Hyperoxygenation 20% FiO2; Other: Hyperinflation (PEEP- ZEEP) Basal FiO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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).
Measured: 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
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).
Measured: Endotracheal suctioning is carried out according each protocol. Baseline Volumetric capnography measures are performed before suctioning, immediately after and 30 minutes the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline R F Vianna, Universidade Federal de Sao Carlos
- Investigators
- Jacqueline RF Vianna, Master, Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440919
- Sponsor's protocol ID
- 11354813.1.0000.5504
- Acronym
- OSVHES
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2015
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 2912927Berney 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.
PubMed 12109234Herbst-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.
PubMed 21914178de 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.
PubMed 32636279Vianna 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.
PubMed 28003557
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction of Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02440919
- Acronym / sponsor ID
- OSVHES / 11354813.1.0000.5504
- Conditions
- Hypoventilation, Hypoxemia
- Keywords
- Respiratory mechanics, Oxygenation, Suction, Mechanical ventilation, Respiratory therapy, Capnography, Pulmonary Ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyperoxygenation - 100% FiO2 | Other | Other: Hyperoxygenation 20% FiO2Hyperoxygenation involved supplying 100% fraction of inspired oxygen (FIO2). |
| Hyperoxygenation - 20% FiO2 | Other | Other: Hyperoxygenation 100% FiO2Hyperoxygenation involved supplying 20% oxygen above FiO2 basal. |
| Hyperinflation - Basal FiO2 | Other | Other: Hyperinflation (PEEP- ZEEP) 20% FiO2Ventilator hyperinflation, with keeping the oxygen already offered to the patient. |
| Hyperinflation - 20% FiO2 | Other | Other: Hyperoxygenation 20% FiO2, Other: Hyperinflation (PEEP- ZEEP) Basal FiO2Ventilator hyperinflation and hyperoxygenation involved supplying 20% oxygen. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation for more than 12h
- Hemodynamic stability
- Presence of indication criteria of endotracheal aspiration procedure
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperoxygenation 100% FiO2Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen. | Other | Hyperoxygenation - 20% FiO2 |
| Hyperoxygenation 20% FiO2Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal. | Other | Hyperinflation - 20% FiO2, Hyperoxygenation - 100% FiO2 |
| Hyperinflation (PEEP- ZEEP) Basal FiO2Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient. | Other | Hyperinflation - 20% FiO2 |
| Hyperinflation (PEEP- ZEEP) 20% FiO2Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen. | Other | Hyperinflation - Basal FiO2 |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 2912927Rogge 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.
- Background: PubMed 12109234Berney 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.
- Background: PubMed 21914178Herbst-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.
- Derived from this study: PubMed 32636279de 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.
- Derived from this study: PubMed 28003557Vianna 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.
- Individual participant dataSharing planned: No
Related trials for Hypoventilation
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
Assessing the Acute Effects of Virtual Reality Interventions on Stress
Slow Breathing
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
Multiple Myeloma, Breathing Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline RF Vianna, Master principal investigator
UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperoxygenation 100% FiO2, Hyperoxygenation 20% FiO2 and Hyperinflation (PEEP- ZEEP) Basal FiO2 in people with Hypoventilation and Hypoxemia, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440919, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.