HypoxiaNCT02913391
Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in Cardiac Surgery.
A study testing recruitment group (RG) in people with Hypoxia, run by Mieko Cláudia Miura at 1 site in Brazil.
Trial summary
Cardiac surgery can evolve with complications in the postoperative period, atelectasis and hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay in the hospital, increasing morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- recruitment group (RG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or over;
- Hypoxemia defined by ratio PaO2/FiO2 < 300 in extubation;
- Glasgow Coma Scale > 11 after extubation;
- Chest radiograph with radiological atelectasis score ≥ 2 The radiological score of atelectasis: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.
Who cannot join
- Use of vasoconstrictor drugs in increasing doses throughout the last two hours (norepinephrine increasing ≥ 0.5 mcg / kg / min, or increase of dopamine ≥ 5mcg/kg/min) or arterial pressure <65 mmHg;
- Presence of a tracheostomy;
- Global initiative for Obstructive Lung Disease (GOLD) classification > 2 and pulmonary fibrosis;
- Contraindication to use of NIV;
- Refuse of RM by the surgeon / doctor in charge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in the Postoperative Period of Coronary Artery Bypass Grafting: a Controlled Randomized Clinical Trial.
Cardiac surgery can evolve with complications in the postoperative period, atelectasis and hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay in the hospital, increasing morbidity and mortality. In order to prevent or reduce such complications noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and therapeutic way. The use of positive end-expiratory pressure (PEEP) is widely practice in intensive care unit (ICU), being used in patients under mechanical ventilation, NIV and exercises with intermittent positive pressure. The recruitment maneuver (RM) consists of sustained increase of pressure in the airway using PEEP in individuals with hypoxemia, in order to minimize the deleterious effects from alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma increasing the pulmonary area available for gas exchange and, consequently, arterial oxygenation. In recent years the increase in the application of PEEP in cardiac patients under has shown great benefits and the use of NIV to improve oxygenation by the reversal of atelectasis is already used and recommended in hospital routine. Despite NIV being used in great proportion, the relevant literature is poor in showing studies with NIV associated with RM in postoperative period of cardiac surgery. Therefore, the aims of this study are to evaluate if the use of NIV associated with RM improves oxygenation and if it can be safely applied in coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) postoperative patients.
Read the detailed description
This work was a controlled and randomized clinical trial, where patients were analyzed in postoperative period of CABG with CPB. The protocol study was approved by Ethics Committee of the Faculty of Medicine, University os São Paulo and the Ethics Committee of the Hospital do Coração. Written informed consent was obtained from the patients or their surrogates at the thime of their enrollment.
Patients, doctors and nursing team were blinded to which group the patient was allocated, only the physiotherapy team, responsible for applying NIV therapy in the study, was aware of group allocation after randomization.
All the patients were ventilated in Servo I (MAQUET Critical Care AB™, Sweden) and used the FitLife total face mask (Philips Respironics™, USA).
Randomization was performed using a computer-based software. Patients eligible to the study were randomly assigned to the Control Group (CG) or Recruitment Group (RG).
CG used NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, fractional inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. RG used NIV with RM with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each level, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.
Patients were monitored during the whole NIV session.The RM would be interrupted and medical staff would be called to check the patient if any clinical instability occurred during or after RM, such as barotrauma, respiratory instability, hemodynamic instability and arrhythmia.
Medical staff would take the required measures for the safety of the patient.
Safety criteria for Interruption of RM:
- respiratory rate > 35 breaths per minute;
- heart rate >120 beats per minute or < 20 points from baseline;
- Systolic blood pressure < 90 mmHg or > 16 mmHg;
- Cardiac arrhythmia;
- Patient's request. The patients used NIV three times per day until discharge from the ICU, the arterial blood gas and chest radiograph examinations were collected as sector routine. The arterial blood samples was collected after 2 minutes in room air and chest radiograph without NIV.
All postoperative patients of the ICU had NIV therapy once in the morning, once in the afternoon, once at night and only the physiotherapist applied NIV. All the patients were guided concerning how their therapy would be and, if they had queries, they were clarified before the start.
- Conditions
- Hypoxia
- Being tested
- recruitment group (RG), control group (CG)
- Keywords
- noninvasive ventilation, myocardial revascularization, pulmonary atelectasis, hypoxia, positive end-expiratory pressure, coronary artery bypass grafting, extracorporeal circulation
- Medical subject headings
- Hypoxia, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment group (RG)Other
After extubation the patient who was randomized to the Recruitment Group will use noninvasive ventilation (NIV) with alveolar recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.
control group (CG)Other
After extubation the patient who was randomized to the Control Group will use noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.
| Study group | Role | What they receive |
|---|---|---|
| recruitment group (RG) | Experimental | After extubation the patient who was randomized to the Recruitment Group (RG) used noninvasive ventilation (NIV) associated with recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV until 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. Receives: Other: recruitment group (RG) |
| control group (CG) | Active comparator | After extubation the patient who was randomized to the Control Group (CG) used noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%. Receives: Other: control group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation improvement
Arterial blood gas sample was collected in pressure support ventilation on the day of extubation and on the following days, it was collected after 2 minutes in room air, daily until ICU discharge. Oxygenation improvement was the difference between partial oxygen pressure at the day of ICU discharge and the day of extubation.
Measured: from date of extubation until the date of ICU discharge, approximately one month
Secondary outcomes (7)
Atelectasis score improvement
Radiological Atelectasis Score was attributed by a physician not related to the study, according to chest radiograph, with the following scores: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.
Measured: from date of extubation until the date of ICU discharge, approximately one month
Barotrauma
Occurrence of pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumoperitoneum during or after noninvasive ventilation associated or not to recruitment maneuver.
Measured: from date of extubation until the date of ICU discharge, approximately one month
Arrhythmia
Occurrence of cardiac arrhythmia during or after noninvasive ventilation associated or not to recruitment maneuver.
Measured: from date of extubation until the date of ICU discharge, approximately one month
Hemodynamic instability
Occurrence of heart rate > 120 beats per minute or < 20 points from baseline value, systolic blood pressure < 90 or > 160 mmHg during or after noninvasive ventilation associated or not to recruitment maneuver.
Measured: from date of extubation until the date of ICU discharge, approximately one month
Extubation failure rate
The failure of extubation was defined as the requirement of reintubation of the extubated patients within a 48hour period.
Measured: from date of extubation until the date of ICU discharge, approximately one month
ICU lenght of stay
Number of days that the patient stayed at the ICU.
Measured: from date of ICU admission until the date of ICU discharge, approximately one month
Mortality intrahospital
Occurrence of death during hospital stay.
Measured: from date of hospital admission until the date of hospital discharge, approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mieko Cláudia Miura
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital do Coracao
- Responsible party
- Sponsor-investigator, Mieko Cláudia Miura, University of Sao Paulo
- Investigators
- Carolina Fu, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913391
- Sponsor's protocol ID
- 044/16
- Other IDs
- 298/2014
- Status last verified
- Jan 2018
- First submitted
- 14 Sep 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Authors may accept to share data regarding baseline characteristics and results. Researchers with interest in the study should contact us by email to request. The request will be analyzed by the study authors.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in the Postoperative Period of Coronary Artery Bypass Grafting: a Controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02913391
- Acronym / sponsor ID
- 044/16
- Conditions
- Hypoxia
- Keywords
- noninvasive ventilation, myocardial revascularization, pulmonary atelectasis, hypoxia, positive end-expiratory pressure, coronary artery bypass grafting, extracorporeal circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mieko Cláudia MiuraUniversity, hospital or other
- Collaborators
- Hospital do Coracao
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Sep 2016 (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.
Cardiac surgery can evolve with complications in the postoperative period, atelectasis and hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay in the hospital, increasing morbidity and mortality. In order to prevent or reduce such complications noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and therapeutic way. The use of positive end-expiratory pressure (PEEP) is widely practice in intensive care unit (ICU), being used in patients under mechanical ventilation, NIV and exercises with intermittent positive pressure. The recruitment maneuver (RM) consists of sustained increase of pressure in the airway using PEEP in individuals with hypoxemia, in order to minimize the deleterious effects from alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma increasing the pulmonary area available for gas exchange and, consequently, arterial oxygenation. In recent years the increase in the application of PEEP in cardiac patients under has shown great benefits and the use of NIV to improve oxygenation by the reversal of atelectasis is already used and recommended in hospital routine. Despite NIV being used in great proportion, the relevant literature is poor in showing studies with NIV associated with RM in postoperative period of cardiac surgery. Therefore, the aims of this study are to evaluate if the use of NIV associated with RM improves oxygenation and if it can be safely applied in coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) postoperative patients.
Detailed description
This work was a controlled and randomized clinical trial, where patients were analyzed in postoperative period of CABG with CPB. The protocol study was approved by Ethics Committee of the Faculty of Medicine, University os São Paulo and the Ethics Committee of the Hospital do Coração. Written informed consent was obtained from the patients or their surrogates at the thime of their enrollment.
Patients, doctors and nursing team were blinded to which group the patient was allocated, only the physiotherapy team, responsible for applying NIV therapy in the study, was aware of group allocation after randomization.
All the patients were ventilated in Servo I (MAQUET Critical Care AB™, Sweden) and used the FitLife total face mask (Philips Respironics™, USA).
Randomization was performed using a computer-based software. Patients eligible to the study were randomly assigned to the Control Group (CG) or Recruitment Group (RG).
CG used NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, fractional inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. RG used NIV with RM with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each level, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.
Patients were monitored during the whole NIV session.The RM would be interrupted and medical staff would be called to check the patient if any clinical instability occurred during or after RM, such as barotrauma, respiratory instability, hemodynamic instability and arrhythmia.
Medical staff would take the required measures for the safety of the patient.
Safety criteria for Interruption of RM:
- respiratory rate > 35 breaths per minute;
- heart rate >120 beats per minute or < 20 points from baseline;
- Systolic blood pressure < 90 mmHg or > 16 mmHg;
- Cardiac arrhythmia;
- Patient's request. The patients used NIV three times per day until discharge from the ICU, the arterial blood gas and chest radiograph examinations were collected as sector routine. The arterial blood samples was collected after 2 minutes in room air and chest radiograph without NIV.
All postoperative patients of the ICU had NIV therapy once in the morning, once in the afternoon, once at night and only the physiotherapist applied NIV. All the patients were guided concerning how their therapy would be and, if they had queries, they were clarified before the start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recruitment group (RG) | Experimental | Other: recruitment group (RG)After extubation the patient who was randomized to the Recruitment Group (RG) used noninvasive ventilation (NIV) associated with recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV until 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. |
| control group (CG) | Active comparator | Other: control group (CG)After extubation the patient who was randomized to the Control Group (CG) used noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or over;
- Hypoxemia defined by ratio PaO2/FiO2 < 300 in extubation;
- Glasgow Coma Scale > 11 after extubation;
- Chest radiograph with radiological atelectasis score ≥ 2 The radiological score of atelectasis: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.
Key exclusion criteria (5 listed)
- Use of vasoconstrictor drugs in increasing doses throughout the last two hours (norepinephrine increasing ≥ 0.5 mcg / kg / min, or increase of dopamine ≥ 5mcg/kg/min) or arterial pressure <65 mmHg;
- Presence of a tracheostomy;
- Global initiative for Obstructive Lung Disease (GOLD) classification > 2 and pulmonary fibrosis;
- Contraindication to use of NIV;
- Refuse of RM by the surgeon / doctor in charge.
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 |
|---|---|---|
| recruitment group (RG)After extubation the patient who was randomized to the Recruitment Group will use noninvasive ventilation (NIV) with alveolar recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%. | Other | recruitment group (RG) |
| control group (CG)After extubation the patient who was randomized to the Control Group will use noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%. | Other | control group (CG) |
Primary outcome
Oxygenation improvement
Time frame: from date of extubation until the date of ICU discharge, approximately one month
Arterial blood gas sample was collected in pressure support ventilation on the day of extubation and on the following days, it was collected after 2 minutes in room air, daily until ICU discharge. Oxygenation improvement was the difference between partial oxygen pressure at the day of ICU discharge and the day of extubation.
7 secondary outcomes
Atelectasis score improvement
Time frame: from date of extubation until the date of ICU discharge, approximately one month
Barotrauma
Time frame: from date of extubation until the date of ICU discharge, approximately one month
Arrhythmia
Time frame: from date of extubation until the date of ICU discharge, approximately one month
Hemodynamic instability
Time frame: from date of extubation until the date of ICU discharge, approximately one month
Extubation failure rate
Time frame: from date of extubation until the date of ICU discharge, approximately one month
ICU lenght of stay
Time frame: from date of ICU admission until the date of ICU discharge, approximately one month
Mortality intrahospital
Time frame: from date of hospital admission until the date of hospital discharge, approximately one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: Undecided. Authors may accept to share data regarding baseline characteristics and results. Researchers with interest in the study should contact us by email to request. The request will be analyzed by the study authors.
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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.
Carolina Fu, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recruitment group (RG) in people with Hypoxia, run by Mieko Cláudia Miura 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygenation improvement (time frame: from date of extubation until the date of ICU discharge, approximately one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.