Non Invasive Pressure Support Ventilation (NIPPV) Versus... | NCT00852384

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

NCT00852384

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Aug 28, 2009Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Obesity

Interventions

NIPPV and IRM

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Feb 26, 2009

First Submission Date that Met QC Criteria

Feb 26, 2009

First Posted Date

Feb 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2009

Last Update Posted Date

Aug 28, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIPPV and IRM	Procedure	non invasive positive pressure support ventilation (NIPPV group) alveolar recruitment maneuver (IRM group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation		5 min after the oneset of mechanical ventilation

Secondary Outcomes

Measure	Description	Time Frame
- FRC after tracheal intubation and after 5 min of mechanical ventilation		after 5 min of mechanichal ventilation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Futier	University Hospital, Clermont-Ferrand	Principal Investigator
Jean-Michel Constantin	University Hospital, Clermont-Ferrand	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Hôtel-Dieu		Clermont-Ferrand		63058	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21478734	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases