Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

Not Applicable

Completed

• Conditions: ENT Cancer Screening
• Interventions: Procedure: Oxygenation with simple breathing mask; Device: positive pressure ventilation

• Registration Number: NCT02167334
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-09
• Status Verified: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygenation with simple breathing mask	Oxygenation 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.
positive pressure ventilation	positive pressure ventilation	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.

Primary Outcome Measures

Name	Time	Method
non hypoxemic apnea time	up to 5 minutes after stopping oxygenation	time the oxygen saturation is going down to 90% during apnea

Secondary Outcome Measures

Name	Time	Method
surgical laryngoscopy frequency	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
preoxygenation time	up to 10 min after the start of oxygenation	time to reach expired oxygen fraction to 90%

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France