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Non Invasive Pressure Support Ventilation (NIPPV) Versus Recruitment Maneuver (RM) and Preoxygenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852384
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : August 28, 2009
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: NIPPV and IRM Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient
Study Start Date : February 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Intervention Details:
  • Procedure: NIPPV and IRM
    • non invasive positive pressure support ventilation (NIPPV group)
    • alveolar recruitment maneuver (IRM group)

Primary Outcome Measures :
  1. Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation [ Time Frame: 5 min after the oneset of mechanical ventilation ]

Secondary Outcome Measures :
  1. - FRC after tracheal intubation and after 5 min of mechanical ventilation [ Time Frame: after 5 min of mechanichal ventilation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Body mass index (BMI > 30 kg/m2)
  • Age > 18 years

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852384

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University Hospital Hôtel-Dieu
Clermont-Ferrand, France, 63058
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Emmanuel Futier University Hospital, Clermont-Ferrand
Study Director: Jean-Michel Constantin University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Emmanuel FUTIER, CHU Clermont-Ferrand Identifier: NCT00852384    
Other Study ID Numbers: CHU-0046
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009
Keywords provided by University Hospital, Clermont-Ferrand:
Anesthesia induction
Obese patients
Noninvasive ventilation
Alveolar recruitment