ObesityPhase 4NCT00852384
Non Invasive Pressure Support Ventilation (NIPPV) Versus Recruitment Maneuver (RM) and Preoxygenation
A Phase 4 study testing NIPPV and IRM in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- NIPPV and IRM
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI > 30 kg/m2)
- Age > 18 years
- ASA I-III
Who cannot join
- Age < 18 years
- Patient refusal
- Pregnancy
- Emergency surgery
- COPD with FEV1 < 50%
- History of pneumothorax
Show all 9Show fewer
- Severe asthma
- Cardiac failure (NYHA > 2)
- Ischemic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- NIPPV and IRM
- Keywords
- Anesthesia induction, Obese patients, Noninvasive ventilation, Alveolar recruitment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPV and IRMProcedure or surgery
- non invasive positive pressure support ventilation (NIPPV group)
- alveolar recruitment maneuver (IRM group)
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation
Measured: 5 min after the oneset of mechanical ventilation
Secondary outcomes (1)
- FRC after tracheal intubation and after 5 min of mechanical ventilation
Measured: after 5 min of mechanichal ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Emmanuel Futier, Principal investigator, University Hospital, Clermont-FerrandJean-Michel Constantin, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852384
- Sponsor's protocol ID
- CHU-0046
- Status last verified
- Aug 2009
- First submitted
- 26 Feb 2009
- Last updated
- 28 Aug 2009
- Results posted
- No
Publications
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.
PubMed 21478734
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient
- ClinicalTrials.gov ID
- NCT00852384
- Acronym / sponsor ID
- CHU-0046
- Conditions
- Obesity
- Keywords
- Anesthesia induction, Obese patients, Noninvasive ventilation, Alveolar recruitment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI > 30 kg/m2)
- Age > 18 years
- ASA I-III
Key exclusion criteria (9 listed)
- Age < 18 years
- Patient refusal
- Pregnancy
- Emergency surgery
- COPD with FEV1 < 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPPV and IRM* non invasive positive pressure support ventilation (NIPPV group) * alveolar recruitment maneuver (IRM group) | Procedure or surgery | – |
Primary outcome
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation
Time frame: 5 min after the oneset of mechanical ventilation
1 secondary outcome
- FRC after tracheal intubation and after 5 min of mechanical ventilation
Time frame: after 5 min of mechanichal ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2009.
- Derived from this study: PubMed 21478734Futier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Futier principal investigator
University Hospital, Clermont-Ferrand
Jean-Michel Constantin study director
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NIPPV and IRM in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation (time frame: 5 min after the oneset of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2009.