NCT00852384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 28, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

February 26, 2009

Last Update Submit

August 27, 2009

Conditions

Obesity

Keywords

Anesthesia inductionObese patientsNoninvasive ventilationAlveolar recruitment

Outcome Measures

Primary Outcomes (1)

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

    5 min after the oneset of mechanical ventilation

Secondary Outcomes (1)

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

    after 5 min of mechanichal ventilation

Interventions

NIPPV and IRMPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI \> 30 kg/m2)
  • Age \> 18 years
  • ASA I-III

You may not qualify if:

  • Age \< 18 years
  • Patient refusal
  • Pregnancy
  • Emergency surgery
  • COPD with FEV1 \< 50%
  • History of pneumothorax
  • Severe asthma
  • Cardiac failure (NYHA \> 2)
  • Ischemic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hôtel-Dieu

Clermont-Ferrand, 63058, France

Location

Related Publications (1)

  • 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.

    PMID: 21478734DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel Futier

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Jean-Michel Constantin

    University Hospital, Clermont-Ferrand

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 28, 2009

Record last verified: 2009-08

Locations

FR(1)