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

NCT ID: NCT00852384

Last Updated: 2009-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Anesthesia induction Obese patients Noninvasive ventilation Alveolar recruitment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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NIPPV and IRM

* non invasive positive pressure support ventilation (NIPPV group)
* alveolar recruitment maneuver (IRM group)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Emmanuel Futier

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Jean-Michel Constantin

Role: STUDY_DIRECTOR

University Hospital, Clermont-Ferrand

Locations

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University Hospital Hôtel-Dieu

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

Reference Type DERIVED
PMID: 21478734 (View on PubMed)

Other Identifiers

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CHU-0046

Identifier Type: -

Identifier Source: org_study_id