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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT00852384
Collaborator
(none)
60
Enrollment
1
Location
5.9
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2009
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation [5 min after the oneset of mechanical ventilation]

Secondary Outcome Measures

  1. - FRC after tracheal intubation and after 5 min of mechanical ventilation [after 5 min of mechanichal ventilation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00852384
Other Study ID Numbers:
  • CHU-0046
First Posted:
Feb 27, 2009
Last Update Posted:
Aug 28, 2009
Last Verified:
Aug 1, 2009
Keywords provided by , ,
Anesthesia induction
Obese patients
Noninvasive ventilation
Alveolar recruitment

Study Results

No Results Posted as of Aug 28, 2009