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OpenTrials
Completed

NCT Number: NCT02167334

Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

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.

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Key information

Conditions

ENT Cancer Screening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

positive pressure ventilation

Device

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.

Other names: non invasive ventilation (NIV)

Oxygenation with simple breathing mask

Procedure

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.

Primary outcomes

  1. non hypoxemic apnea time

    Time frame: up to 5 minutes after stopping oxygenation

    time the oxygen saturation is going down to 90% during apnea

Secondary outcomes

  1. surgical laryngoscopy frequency

    Time frame: up to 15 minutes after stopping oxygenation

    number of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea

  2. preoxygenation time

    Time frame: up to 10 min after the start of oxygenation

    time to reach expired oxygen fraction to 90%

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: PANNIV

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2014
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.