Preoxygenation Optimisation in Obese Patients

Severe Obesity Design as BMI > 35kg/m2 Clinical Trial

— PREOPTI-POOP  

Official title:

PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106441
• Other study ID #: RC17_0046
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: September 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

Description:

This study will be designed as followed : Patients will be randomized in 2 groups :

• Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.

• Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Obese patient with BMI > 35kg/m2

• Age between 18 and 80 years

• Requiring a crash induction sequence for oro-tracheal intubation.

Exclusion Criteria:

• Pulse oxymetry < 90% in ambient air

• Haemodynamic instability

• Burned patient

• Indication of intubation vigil in spontaneous ventilation

• Patients with a documented Cormack IV exposition before inclusion

• Protected adult

• Pregnancy

• Lack of consent

• Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.

• Lack of French social protection

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity Design as BMI > 35kg/m2

Intervention

Device:
• High flow oxygen therapy by nasal cannula. Optiflow®
Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
• Facial mask oxygenation in BIPAP ventilation
Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision

Locations

Country	Name	City	State
France	Nantes University Hospital, Hôtel Dieu, Medical intensive care unit	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expired fraction of oxygen at the end of intubation	To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.	2 minutes
Secondary	Improvement of quality of preoxygenation	duration of proceedings	4 minutes
Secondary	Reduction in side effects incidence related to intubation	Notification of adverse events during the intubation period	1 hour
Secondary	morbi-mortality during surgery	Per and postoperative complication rate	6 hour