ENT Cancer ScreeningPANNIVNCT02167334
Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.
A study testing positive pressure ventilation and Oxygenation with simple breathing mask in people with ENT Cancer Screening, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ENT Cancer Screening
- What is being tested?
- positive pressure ventilation and Oxygenation with simple breathing mask
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jun 2014
- 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
- patient going for scheduled panendoscopy under general anesthesia
Who cannot join
- BMI upper to 35 kg/m2
- pregnancy
- requirement of jet ventilation
- tracheostomy
- acute respiratory failure: pneumonia, pulmonary embolism
- health insurance careless
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.
the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.
the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.
- Conditions
- ENT Cancer Screening
- Being tested
- positive pressure ventilation, Oxygenation with simple breathing mask
- Keywords
- panendoscopy, preoxygenation, non invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive pressure ventilationDevice
Also called non invasive ventilation (NIV)
Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.
Oxygenation with simple breathing maskProcedure or surgery
Spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.
| Study group | Role | What they receive |
|---|---|---|
| positive pressure ventilation | Experimental | Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow. Receives: Device: positive pressure ventilation |
| Oxygenation with simple breathing mask | Active comparator | spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume. Receives: Procedure: Oxygenation with simple breathing mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
non hypoxemic apnea time
time the oxygen saturation is going down to 90% during apnea
Measured: up to 5 minutes after stopping oxygenation
Secondary outcomes (2)
surgical laryngoscopy frequency
number of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea
Measured: up to 15 minutes after stopping oxygenation
preoxygenation time
time to reach expired oxygen fraction to 90%
Measured: up to 10 min after the start of oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2013
- Study completionJun 2014
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 ENT Cancer ScreeningStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama ABOU ARAB, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167334
- Sponsor's protocol ID
- PI12-DR-DIMOV
- Other IDs
- 2012-A01053-40
- Acronym
- PANNIV
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2014
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394.
PubMed 26716862
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT02167334
- Acronym / sponsor ID
- PANNIV / PI12-DR-DIMOV
- Conditions
- ENT Cancer Screening
- Keywords
- panendoscopy, preoxygenation, non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Jun 2014 (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.
the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.
the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive pressure ventilation | Experimental | Device: positive pressure ventilationPositive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow. |
| Oxygenation with simple breathing mask | Active comparator | Procedure: Oxygenation with simple breathing maskspontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient going for scheduled panendoscopy under general anesthesia
Key exclusion criteria (6 listed)
- BMI upper to 35 kg/m2
- pregnancy
- requirement of jet ventilation
- tracheostomy
- acute respiratory failure: pneumonia, pulmonary embolism
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 |
|---|---|---|
| positive pressure ventilationAlso: non invasive ventilation (NIV)Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow. | Device | positive pressure ventilation |
| Oxygenation with simple breathing maskSpontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume. | Procedure or surgery | Oxygenation with simple breathing mask |
Primary outcome
non hypoxemic apnea time
Time frame: up to 5 minutes after stopping oxygenation
time the oxygen saturation is going down to 90% during apnea
2 secondary outcomes
surgical laryngoscopy frequency
Time frame: up to 15 minutes after stopping oxygenation
preoxygenation time
Time frame: up to 10 min after the start of oxygenation
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 22 Sep 2025.
- Results publication: PubMed 26716862Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394.
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.
Osama ABOU ARAB, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive pressure ventilation and Oxygenation with simple breathing mask in people with ENT Cancer Screening, run by Centre Hospitalier Universitaire, Amiens 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 1 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: finished, as of the sponsor's last update on 22 Sep 2025. 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?
non hypoxemic apnea time (time frame: up to 5 minutes after stopping oxygenation). 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 NCT02167334, 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 22 Sep 2025.