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

Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00852384
Enrollment
60
Registered
2009-02-27
Start date
2009-02-28
Completion date
2009-08-31
Last updated
2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Anesthesia induction, Obese patients, Noninvasive ventilation, Alveolar recruitment

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.

Interventions

PROCEDURENIPPV and IRM

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation5 min after the oneset of mechanical ventilation

Secondary

MeasureTime frame
- FRC after tracheal intubation and after 5 min of mechanical ventilationafter 5 min of mechanichal ventilation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026