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Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02167334
Acronym
PANNIV
Enrollment
50
Registered
2014-06-19
Start date
2013-09-30
Completion date
2014-06-30
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ENT Cancer Screening

Keywords

panendoscopy, preoxygenation, non invasive ventilation

Brief 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. the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.

Interventions

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.

PROCEDUREOxygenation with simple breathing mask

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient going for scheduled panendoscopy under general anesthesia

Exclusion criteria

* BMI upper to 35 kg/m2 * pregnancy * requirement of jet ventilation * tracheostomy * acute respiratory failure: pneumonia, pulmonary embolism * health insurance careless

Design outcomes

Primary

MeasureTime frameDescription
non hypoxemic apnea timeup to 5 minutes after stopping oxygenationtime the oxygen saturation is going down to 90% during apnea

Secondary

MeasureTime frameDescription
surgical laryngoscopy frequencyup to 15 minutes after stopping oxygenationnumber of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea
preoxygenation timeup to 10 min after the start of oxygenationtime to reach expired oxygen fraction to 90%

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026