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Clinical Trials/NCT00852384
NCT00852384
Completed
Phase 4

Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

University Hospital, Clermont-Ferrand1 site in 1 country60 target enrollmentFebruary 2009
ConditionsObesity

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Obesity
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
60
Locations
1
Primary Endpoint
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
August 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand

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

Outcomes

Primary Outcomes

Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation

Time Frame: 5 min after the oneset of mechanical ventilation

Secondary Outcomes

  • - FRC after tracheal intubation and after 5 min of mechanical ventilation(after 5 min of mechanichal ventilation)

Study Sites (1)

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