Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

NCT02167334 | Completed

• 2 other identifiers: PI12-DR-DIMOV2012-A01053-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

ENT Cancer Screening

Keywords

panendoscopy; preoxygenation; non invasive ventilation

Outcome Measures

Primary Outcomes (1)

• non hypoxemic apnea time

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

  up to 5 minutes after stopping oxygenation

Secondary Outcomes (2)

• surgical laryngoscopy frequency

  up to 15 minutes after stopping oxygenation

• preoxygenation time

  up to 10 min after the start of oxygenation

Study Arms (2)

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.

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.

Procedure: Oxygenation with simple breathing mask

Interventions

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.

Also known as: non invasive ventilation (NIV)

positive pressure ventilation

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.

Oxygenation with simple breathing mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient going for scheduled panendoscopy under general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

Related Publications (1)

• 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.

  PMID: 26716862 RESULT

MeSH Terms

Interventions

Positive-Pressure Respiration; Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Osama ABOU ARAB, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 19, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (1)