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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00852384
First received: February 26, 2009
Last updated: August 27, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Clermont-Ferrand

Additional 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
Study First Received: February 26, 2009
Last Updated: August 27, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Anesthesia induction
Obese patients
Noninvasive ventilation
Alveolar recruitment
obese patients

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014