Clinical trial NCT00852384: Non Invasive Pressure Support Ventilation (NIPPV) Versus Recruitment Maneuver (RM) and Preoxygenation
Official title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Anesthesia induction
Obese patients
Noninvasive ventilation
Alveolar recruitment
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

Detailed description: Atelectasis formation during general anesthesia, leading to reduced end-expiratory lung volume, is an important cause of intrapulmonary shunt leading to impaired gas-exchange and hypoxemia. During general anesthesia and the immediate postoperative period, morbidly obese patients, who develop a larger amount of atelectasis than non-obese patient, are more likely to present impairment of gas exchange and respiratory mechanics. Noninvasive positive-pressure support ventilation (NIPPV) and positive end-expiratory pressure (PEEP) are effective to provide oxygenation during intubation of hypoxemic patients. Recent data suggest that NIPPV enhances preoxygenation in morbidly obese patients. Moreover, the application of PEEP during induction of anesthesia prevents atelectasis formation and increases nonhypoxic apnea duration in obese patients despite the use of high-inspired oxygen fraction. However, the use of both NIPPV is widely used in the operating room, because of technical and materials constraints.

Several trials have demonstrated that alveolar recruitment maneuvers (RM) are effective to remove atelectasis and improve lungs mechanics and gas-exchange.

The purpose of this randomized and controlled study is to compare the effects of two ventilatory strategies during anesthesia induction of morbidly obese patients on both gas-exchange and functional residual capacity (FRC) modifications: 1- Control group: preoxygenation using 100% O2 via a face-mask and PEEP 10 cmH2O after intubation; 2- NIPPV group: preoxygenation using NIPPV and PEEP 10 cmH2O after intubation; 3- RM group: preoxygenation using 100% O2 via a face-mask and early RM plus PEEP 10 cmH2O after intubation.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI \> 30 kg/m2)
* Age \> 18 years
* ASA I-III

Exclusion Criteria:

* Age \< 18 years
* Patient refusal
* Pregnancy
* Emergency surgery
* COPD with FEV1 \< 50%
* History of pneumothorax
* Severe asthma
* Cardiac failure (NYHA \> 2)
* Ischemic heart disease

Primary outcomes:
measure: Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation
timeFrame: 5 min after the oneset of mechanical ventilation
Secondary outcomes:
measure: - FRC after tracheal intubation and after 5 min of mechanical ventilation
timeFrame: after 5 min of mechanichal ventilation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital Hôtel-Dieu
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel Futier
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel Constantin
role: STUDY_DIRECTOR
References:
citation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.