Cardiac ElectrophysiologyVNI-RYTHMONCT02779998
Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
A study testing non invasive ventilation and Standard oxygen therapy with facial mask in people with Cardiac Electrophysiology and Anesthesia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. Non invasive ventilation (NIV) is recommended for acute cardiogenic pulmonary oedema and sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Electrophysiology, Anesthesia, Acute Respiratory Failure
- What is being tested?
- non invasive ventilation and Standard oxygen therapy with facial mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Dec 2018
- 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
- Age of 18 years old or above
- Procedure in electrophysiology laboratory
- High risk patient defined by an American Society of Anesthesiology (ASA) score of 3 or 4
Who cannot join
- Planned orotracheal intubation
- ASA 1 or 2
- Sleep apnea treated with home non invasive ventilation
- Major contraindication to NIV use
- Pregnancy
- Consent refusal
- Patients protected under the French Law L1121-5 to L1121-8
Trial locations and contacts
1 site in 1 country.
About this study
Acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. Non invasive ventilation (NIV) is recommended for acute cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric, prospective, randomized controlled trial to compare the efficacy of NIV which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event. Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and hypoxia during procedure in rhythmology under light sedation.
Read the detailed description
This study is an investigator-initiated, monocentric, two-arm parallel-group trial with electronic system based randomization. The study protocol was approved by a Central Ethics Committee (France) according to French law. Our teaching hospital have a long experience with peroperative use of NIV during light sedation and acute respiratory failure. This study is designed as a PROBE study (Prospective Randomized Open with Blinded Evaluation) : the investigators will provide a blinded analysis of peroperative computer collected data.
- Being tested
- non invasive ventilation, Standard oxygen therapy with facial mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilationOther
non invasive ventilation is delivered by a specific respirator with inspiratory help mode. NIV mask and parameters are adapted to obtains a Tidal volume ≤ to 8 ml/kg/cycle (if possible ≤ 6 ml/kg/cycle) and a SpO2 superior of 94%.
Standard oxygen therapy with facial maskOther
| Study group | Role | What they receive |
|---|---|---|
| standard oxygen therapy with facial mask | Active comparator | Patients assigned to standard medical therapy will received supplemental oxygen via a facial Venturi mask at a rate of up to 15 liters per minute in order to maintain peripheral oxygen saturation (SpO2) above 94% during electrophysiology procedure under light sedation. Receives: Other: Standard oxygen therapy with facial mask |
| non invasive ventilation | Experimental | non invasive ventilation (NIV) which associated positive end expiratory pressure (PEEP: 5 to 10 cmH2O) and pressure support ventilation (PSV: 5 to 15 cmH2O, to achieve total Pressure bellow 20cmH2O) will be delivered during electrophysiology procedure under light sedation. The patient will received supplemental oxygen through facial mask to achieve an oxygen saturation level above 94%. Receives: Other: non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory event
Based on computer analysis:
- Hypoxia (pulse oxymetry below 90%)
- Apnea (No respiratory cycle measured by End-Tidal carbon dioxygen (CO2) for more than 20 seconds)
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary outcomes (13)
Occurence of hemodynamic instability
Based on computer analysis and defined as: low blood pressure or bradycardia with need of catecholamine drugs or volume resuscitation.
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory rate
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
End-Tidal carbon dioxygen
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Tidal Volume
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory settings of NIV ventilator
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
O2 inspiration fraction
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Bispectral Index variability
Based on computer analysis
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Occurence of a major medical event
A major medical event is defined as
- pneumothorax,
- oro-tracheal intubation or laryngeal mask,
- cardiopulmonary resuscitation,
- surgical complication
- pleural or pericardia effusion drain use
- Intervention from anesthesiologist
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Occurence of a minor medical event
A minor medical event is defined as
- NIV mask related skin injuries,
- nausea or vomiting,
- aspiration
Guedel canula,
- mandibular subluxation
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Procedure failure
Procedure failure is defined as the change of oxygen device or the change of ventilatory mode (controlled mode)
Measured: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Patient status
A composite outcome defined as the occurence of:
- death,
- cardiac complication (acute heart failure, infarcts),
- acute respiratory failure
- pneumopathy
Measured: within 7 days after procedure
Length of hospital stay
Measured: within 7 days after procedure
Length of Intensive Care Unit (ICU) stay
Measured: within 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ElectrophysiologyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779998
- Sponsor's protocol ID
- 38RC15.163
- Acronym
- VNI-RYTHMO
- Status last verified
- Nov 2020
- First submitted
- 12 May 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Moury PH, Pasquier V, Greco F, Arvieux JL, Alves-Macedo S, Richard M, Casez-Brasseur M, Skaare K, Jacon P, Durand M, Bedague D, Jaber S, Bosson JL, Albaladejo P. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory. Can J Anaesth. 2023 Jul;70(7):1182-1193. doi: 10.1007/s12630-023-02495-2. Epub 2023 Jun 2.
PubMed 37268802
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
- ClinicalTrials.gov ID
- NCT02779998
- Acronym / sponsor ID
- VNI-RYTHMO / 38RC15.163
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 May 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.
Acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. Non invasive ventilation (NIV) is recommended for acute cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric, prospective, randomized controlled trial to compare the efficacy of NIV which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event. Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and hypoxia during procedure in rhythmology under light sedation.
Detailed description
This study is an investigator-initiated, monocentric, two-arm parallel-group trial with electronic system based randomization. The study protocol was approved by a Central Ethics Committee (France) according to French law. Our teaching hospital have a long experience with peroperative use of NIV during light sedation and acute respiratory failure. This study is designed as a PROBE study (Prospective Randomized Open with Blinded Evaluation) : the investigators will provide a blinded analysis of peroperative computer collected data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard oxygen therapy with facial mask | Active comparator | Other: Standard oxygen therapy with facial maskPatients assigned to standard medical therapy will received supplemental oxygen via a facial Venturi mask at a rate of up to 15 liters per minute in order to maintain peripheral oxygen saturation (SpO2) above 94% during electrophysiology procedure under light sedation. |
| non invasive ventilation | Experimental | Other: non invasive ventilationnon invasive ventilation (NIV) which associated positive end expiratory pressure (PEEP: 5 to 10 cmH2O) and pressure support ventilation (PSV: 5 to 15 cmH2O, to achieve total Pressure bellow 20cmH2O) will be delivered during electrophysiology procedure under light sedation. The patient will received supplemental oxygen through facial mask to achieve an oxygen saturation level above 94%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years old or above
- Procedure in electrophysiology laboratory
- High risk patient defined by an American Society of Anesthesiology (ASA) score of 3 or 4
Key exclusion criteria (7 listed)
- Planned orotracheal intubation
- ASA 1 or 2
- Sleep apnea treated with home non invasive ventilation
- Major contraindication to NIV use
- Pregnancy
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 |
|---|---|---|
| non invasive ventilationnon invasive ventilation is delivered by a specific respirator with inspiratory help mode. NIV mask and parameters are adapted to obtains a Tidal volume ≤ to 8 ml/kg/cycle (if possible ≤ 6 ml/kg/cycle) and a SpO2 superior of 94%. | Other | non invasive ventilation |
| Standard oxygen therapy with facial mask | Other | standard oxygen therapy with facial mask |
Primary outcome
Respiratory event
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Based on computer analysis: * Hypoxia (pulse oxymetry below 90%) * Apnea (No respiratory cycle measured by End-Tidal carbon dioxygen (CO2) for more than 20 seconds)
13 secondary outcomes
Occurence of hemodynamic instability
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory rate
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
End-Tidal carbon dioxygen
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Tidal Volume
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory settings of NIV ventilator
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
O2 inspiration fraction
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Bispectral Index variability
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Occurence of a major medical event
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Occurence of a minor medical event
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Procedure failure
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Patient status
Time frame: within 7 days after procedure
Length of hospital stay
Time frame: within 7 days after procedure
Length of Intensive Care Unit (ICU) stay
Time frame: within 7 days after procedure
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 5 Nov 2020.
- Derived from this study: PubMed 37268802Moury PH, Pasquier V, Greco F, Arvieux JL, Alves-Macedo S, Richard M, Casez-Brasseur M, Skaare K, Jacon P, Durand M, Bedague D, Jaber S, Bosson JL, Albaladejo P. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory. Can J Anaesth. 2023 Jul;70(7):1182-1193. doi: 10.1007/s12630-023-02495-2. Epub 2023 Jun 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive ventilation and Standard oxygen therapy with facial mask in people with Cardiac Electrophysiology and Anesthesia, run by University Hospital, Grenoble at 1 site in France.
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 7 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 5 Nov 2020. 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 France. 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?
Respiratory event (time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)). 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 NCT02779998, which also lists 1 linked publication.
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 5 Nov 2020.