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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852384
First Posted: February 27, 2009
Last Update Posted: August 28, 2009
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.
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
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 Intervention Phase
Obesity Procedure: NIPPV and IRM Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital, Clermont-Ferrand:

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

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

Estimated Enrollment: 60
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: NIPPV and IRM
    • non invasive positive pressure support ventilation (NIPPV group)
    • alveolar recruitment maneuver (IRM group)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00852384


Locations
France
University Hospital Hôtel-Dieu
Clermont-Ferrand, France, 63058
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel Futier University Hospital, Clermont-Ferrand
Study Director: Jean-Michel Constantin University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emmanuel FUTIER, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00852384     History of Changes
Other Study ID Numbers: CHU-0046
First Submitted: February 26, 2009
First Posted: February 27, 2009
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