COPD ExacerbationComPaNIVNCT06212180
Comfort of Patients Under Non Invasive Ventilation According to the Mask
An observational study of COPD Exacerbation and Hypercapnia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Hypercapnia, Hypoventilation Obesity Syndrome
- What is being tested?
- mask
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2024to Dec 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.
Who may be able to join
- Indication of NIV, carried out by the physicians in charge of the patient, among the following:
- COPD exacerbation
- Hydrostatic acute pulmonary edema
- Acute Chest Syndrome with Hypercapnia in Sickle Cell Patients
- Post-extubation, planned in a patient at risk or recovering from extubation failure
- Hypoventilation-obesity syndrome
Who cannot join
- Formal contraindication to NIV among:
- Indication for orotracheal intubation at the outset
- Non-cooperative, agitated, opponent of the technique
- Coma
- Respiratory exhaustion
- Shock, severe ventricular arrhythmias, immediate aftermath of cardiac arrest
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- Undrained pneumothorax, blowing chest wound
- Upper airway obstruction (except sleep apnea, laryngotracheomalacia)
- Uncontrollable vomiting
- Upper gastrointestinal bleeding
- Measure of protection of justice
- Facial deformity
- Dying or palliative care patient
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue
Créteil
Armand Mekontso Dessap, MD
CHU Bicêtre - Unité de Soins Intensifs Pneumologique
Le Kremlin-Bicêtre, 94270
Laurent SAVALE, MD, Laurent.savale@aphp.fr
CHU Bicêtre - USC
Le Kremlin-Bicêtre, 94270
Christophe CARPENTIER, MD, 0145217138 ext. 33, christophe.carpentier@aphp.fr
Tai PHAM, MD, tai.pham@aphp.fr
About this study
Official title: Comparison of the Comfort of Patients Under Non-invasive Ventilation According to the Use of a Sub Nasal Mask Versus an Oronasal Mask
A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.
Read the detailed description
Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.
- Conditions
- COPD Exacerbation, Hypercapnia, Hypoventilation Obesity Syndrome, Acute Respiratory Failure
- Being tested
- mask
- Keywords
- Non-invasive ventilation, Acute respiratory failure, Comfort
- Medical subject headings
- Hypercapnia, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maskDevice
Also called oronasal mask or subnasal mask
patients will be their own comparator. Patients will try both mask for 10 min and then decide which mask they want for the rest of the ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
1 to 10 self assessment scale
Comfort will be assessed by a numerical self-assessment scale from 0 to 10.
Measured: throughout the study (an average of 10 months)
Secondary outcomes (5)
Percentage of subjects who prefer one type of mask over the other
Measured: throughout the study (an average of 10 months)
Percentage of leakage volume compared to the tidal leakage volume
Measured: throughout the study (an average of 10 months)
Dyspnea
Measured: throughout the study (an average of 10 months)
Number of interventions on mask position by nurses during NIV session
Measured: throughout the study (an average of 10 months)
Number of side effects
Measured: throughout the study (an average of 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe CARPENTIER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212180
- Sponsor's protocol ID
- APHP231673
- Other IDs
- 2023-A02093-42
- Acronym
- ComPaNIV
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Comfort of Patients Under Non-invasive Ventilation According to the Use of a Sub Nasal Mask Versus an Oronasal Mask
- ClinicalTrials.gov ID
- NCT06212180
- Acronym / sponsor ID
- ComPaNIV / APHP231673
- Conditions
- COPD Exacerbation, Hypercapnia, Hypoventilation Obesity Syndrome, Acute Respiratory Failure
- Keywords
- Non-invasive ventilation, Acute respiratory failure, Comfort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- 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.
A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.
Detailed description
Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.
Key inclusion criteria (6 listed)
- Indication of NIV, carried out by the physicians in charge of the patient, among the following:
- COPD exacerbation
- Hydrostatic acute pulmonary edema
- Acute Chest Syndrome with Hypercapnia in Sickle Cell Patients
- Post-extubation, planned in a patient at risk or recovering from extubation failure
Key exclusion criteria (14 listed)
- Indication for orotracheal intubation at the outset
- Non-cooperative, agitated, opponent of the technique
- Coma
- Respiratory exhaustion
- Shock, severe ventricular arrhythmias, immediate aftermath of cardiac arrest
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 |
|---|---|---|
| maskAlso: oronasal mask or subnasal maskpatients will be their own comparator. Patients will try both mask for 10 min and then decide which mask they want for the rest of the ventilation | Device | – |
Primary outcome
1 to 10 self assessment scale
Time frame: throughout the study (an average of 10 months)
Comfort will be assessed by a numerical self-assessment scale from 0 to 10.
5 secondary outcomes
Percentage of subjects who prefer one type of mask over the other
Time frame: throughout the study (an average of 10 months)
Percentage of leakage volume compared to the tidal leakage volume
Time frame: throughout the study (an average of 10 months)
Dyspnea
Time frame: throughout the study (an average of 10 months)
Number of interventions on mask position by nurses during NIV session
Time frame: throughout the study (an average of 10 months)
Number of side effects
Time frame: throughout the study (an average of 10 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Christophe CARPENTIER, MD principal investigator
Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and Hypercapnia, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe CARPENTIER, MD (0145217138 ext. 33, christophe.carpentier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 to 10 self assessment scale (time frame: throughout the study (an average of 10 months)). 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 18 Jan 2024.