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AzTrials

Bariatric SurgeryNCT02579798

Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

A study testing PEEP (positive end-expiratory pressure) in people with Bariatric Surgery, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bariatric Surgery
What is being tested?
PEEP (positive end-expiratory pressure)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBelgium
Study dates
Jul 2013to Mar 2016
Phase
Interventional
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA score (American Society of Anesthesiologists ) of II or III
  • BMI > 35 kg/m²
  • Elective laparoscopic bariatric surgery: gastric bypass or sleeve

Who cannot join

  • Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease
  • Increase of the intracranial pressure
  • History of smoking with chronic obstructive disease (VEMS/CV)
  • Active tabagism
  • Ongoing pregnancy
  • History of heart failure (NYHA III or IV) or coronary artery disease
Show all 9Show fewer
  • Urgent surgery
  • Allergy to a drug used within the study
  • Lack of written informed consent

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU Brugmann

    Brussels, 1020

Other trials in Belgium

About this study

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.

The functional residual capacity (FRC) of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.

Read more

Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.

There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.

The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.

The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient (arterial and end tidal gradient) between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).

The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

Read the detailed description

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.

These atelectasis are formed on one hand by the reduction of the functional residual capacity (FRC) following a compression mechanism (loss of the inspiratory muscle tone, which is accompanied by a chest wall configuration change and a diaphragm cephalic movement) and on the other hand by a denitrogenation absorption process (ventilation at high Fi02 (oxygen inspired fraction) causing complete absorption of O2 with lack of support for the alveolus, which then collapses).

The FRC of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.

Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.

Several strategies have been studied in order to improve respiratory mechanics and reduce impaired gas exchange during laparoscopic surgery in obese patients. The position called "chair", mechanical ventilation with PEEP, recruitment maneuvers followed by the PEEP, and spontaneous ventilation with CPAP before extubation, are all strategies that have proven effective to decrease development these atelectasis.

Currently, the scientific community agrees on the fact that PEEP improves intraoperative respiratory function (improved compliance, oxygenation) especially in conjunction with recruitment maneuvers.

But there is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.

The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.

The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio, the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).

The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

Being tested
PEEP (positive end-expiratory pressure)
Keywords
Bariatric surgery, Post-surgery hypoxemia, Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP (positive end-expiratory pressure)Device

Study groups in NCT02579798
Study groupRoleWhat they receive
PEEP 10 cmH20ExperimentalIn this group, a PEEP of 10 cmH20 is applied for the duration of the intervention and a recruitment maneuver is applied each time the SpO2 (oxygen pulsated saturation) drops below 95%.
Receives: Device: PEEP (positive end-expiratory pressure)
optimal PEEPActive comparatorIn this group, 10 cmH20 PEEP is applied immediately. Then the "optimal PEEP" is sought at three key moments. It is determined by the best value of lung compliance found in the patient. It is sought by increasing or decreasing the value of the PEEP by increments or decrements of 2 cmH20. If after 6 respiratory cycles, the value of the compliance is increased, the investigator continues to increase the value of the PEEP. On the other hand, if the value of compliance is reduced, the investigator reduces the value of PEEP. The value of the PEEP selected shall in no event exceed the set pressure range (maximum pressure plate of 30 cmH20 and maximum inspiratory peak pressure 40cmH20). A recruitment maneuver is applied each time the SpO2 drops below 95%, as in the PEEP 10cmH2O group.
Receives: Device: PEEP (positive end-expiratory pressure)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of hypoxemia episodes (Sp02<90%)

    This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period.

    Measured: continuously during 48h after surgery

  2. Number of hypoxemia episodes (Sp02<95%)

    This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period.

    Measured: continuously during 48h after surgery

Secondary outcomes (60)

  1. Number of recruitment manoeuvers

    Recruitment manoeuver are performed if patient saturation drops below 95%.

    Measured: From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)

  2. Number of recruitment manoeuvers

    Recruitment manoeuver are performed if patient saturation drops below 95%.

    Measured: From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)

  3. Number of recruitment manoeuvers

    Recruitment manoeuver are performed if patient saturation drops below 95%.

    Measured: From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)

  4. Number of recruitment manoeuvers

    Recruitment manoeuver are performed if patient saturation drops below 95%.

    Measured: From moment 3 till the end of the surgery (patient leaving the theater)

  5. Pulmonary dynamic compliance (Cd) - preoperative

    This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

    Measured: Just before surgery, at ambient air contact

  6. Pulmonary dynamic compliance (Cd) - moment 1

    This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

    Measured: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory

  7. Pulmonary dynamic compliance (Cd) -moment 2

    This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  8. Pulmonary dynamic compliance (Cd) -moment 3

    This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  9. Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers

    This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

    Measured: Five minutes after any recruitment manoeuver

  10. Anatomic dead space - preoperative

    This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)

    Measured: Just before surgery, at ambient air contact

  11. Anatomic dead space -moment 1

    This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)

    Measured: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory

  12. Anatomic dead space -moment 2

    This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  13. Anatomic dead space -moment 3

    This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  14. Anatomic dead space -if recruitment manoeuvers

    This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)

    Measured: Five minutes after any recruitment manoeuver

  15. PaO2/FiO2 ratio - preoperative

    Arterial oxygen partial pressure to fractional inspired oxygen ratio

    Measured: Just before surgery, at ambient air contact

  16. PaO2/FiO2 ratio - moment 1

    Arterial oxygen partial pressure to fractional inspired oxygen ratio

    Measured: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory

  17. PaO2/FiO2 ratio - moment 2

    Arterial oxygen partial pressure to fractional inspired oxygen ratio

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  18. PaO2/FiO2 ratio - moment 3

    Arterial oxygen partial pressure to fractional inspired oxygen ratio

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  19. PaO2/FiO2 ratio - if recruitment manoeuvers

    Arterial oxygen partial pressure to fractional inspired oxygen ratio

    Measured: Five minutes after any recruitment manoeuver

  20. PaCO2-EtCO2 gradient - preoperative

    The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.

    Measured: Just before surgery, at ambient air contact

  21. PaCO2-EtCO2 gradient - moment 1

    The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.

    Measured: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory

  22. PaCO2-EtCO2 gradient - moment 2

    The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  23. PaCO2-EtCO2 gradient - moment 3

    The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  24. PaCO2-EtCO2 gradient - if recruitment manoeuvers

    The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.

    Measured: Five minutes after any recruitment manoeuver

  25. Number of respiratory complications

    Number of hospitalisations due to respiratory complications within 30 days after surgery.

    Measured: 30 days after surgery

  26. Number of postoperative wound infections

    All patients are seen at the surgical consultation on day 30 after surgery. The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation).

    Measured: 30 days after surgery

  27. Pre-operative physiologic measures: cardiac frequency (FC)

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Just before surgery, at ambient air contact

  28. Pre-operative physiologic measures: Arterial tension (TA)

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Just before surgery, at ambient air contact

  29. Pre-operative physiologic measures: pH

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Just before surgery, at ambient air contact

  30. Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).

    Measured: Just before surgery, at ambient air contact

  31. Operative physiologic measures - moment 1: FC

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  32. Operative physiologic measures - moment 1: PAM (Average arterial pressure)

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  33. Operative physiologic measures - moment 1: pH

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  34. Operative physiologic measures - moment 1: PaCO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  35. Operative physiologic measures - moment 1: CO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  36. Operative physiologic measures - moment 2: FC

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  37. Operative physiologic measures - moment 2: PAM

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  38. Operative physiologic measures - moment 2: pH

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  39. Operative physiologic measures - moment 2: PaCO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  40. Operative physiologic measures - moment 2: CO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  41. Operative physiologic measures - moment 3: FC

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  42. Operative physiologic measures - moment 3: PAM

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  43. Operative physiologic measures - moment 3: pH

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  44. Operative physiologic measures - moment 3: CO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  45. Operative physiologic measures - moment 3: PaCO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  46. Operative physiologic measures - if recruitment manoeuvers occurs: FC

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Five minutes after any recruitment manoeuver

  47. Operative physiologic measures - if recruitment manoeuvers occurs: PAM

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Five minutes after any recruitment manoeuver

  48. Operative physiologic measures - if recruitment manoeuvers occurs: SpO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Five minutes after any recruitment manoeuver

  49. Operative physiologic measures - if recruitment manoeuvers occurs: pH

    The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).

    Measured: Five minutes after any recruitment manoeuver

  50. Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Five minutes after any recruitment manoeuver

  51. Operative physiologic measures - if recruitment manoeuvers occurs: PaO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Five minutes after any recruitment manoeuver

  52. Operative physiologic measures - if recruitment manoeuvers occurs: CO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Five minutes after any recruitment manoeuver

  53. Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Just before surgery, at ambient air contact

  54. Operative physiologic measures - moment 1: PaO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  55. Operative physiologic measures - moment 2: PaO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  56. Operative physiologic measures - moment 3: PaO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

  57. Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: Just before surgery, at ambient air contact

  58. Operative physiologic measures - moment 1: SpO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after induction/intubation, patient laying flat, without pneumoperitoneum

  59. Operative physiologic measures - moment 2: SpO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation

  60. Operative physiologic measures - moment 3: SpO2

    The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

    Measured: just after pneumoperitoneum exsufflation - patient lying flat

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02579798
Sponsor's protocol ID
CHUB-CRF
Status last verified
Jan 2018
First submitted
12 Oct 2015
Last updated
19 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.

    PubMed 15105237

  • Imberger G, McIlroy D, Pace NL, Wetterslev J, Brok J, Moller AM. Positive end-expiratory pressure (PEEP) during anaesthesia for the prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007922. doi: 10.1002/14651858.CD007922.pub2.

    PubMed 20824871

  • Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.

    PubMed 12456460

  • Whalen FX, Gajic O, Thompson GB, Kendrick ML, Que FL, Williams BA, Joyner MJ, Hubmayr RD, Warner DO, Sprung J. The effects of the alveolar recruitment maneuver and positive end-expiratory pressure on arterial oxygenation during laparoscopic bariatric surgery. Anesth Analg. 2006 Jan;102(1):298-305. doi: 10.1213/01.ane.0000183655.57275.7a.

    PubMed 16368847

  • Futier E, Constantin JM, Pelosi P, Chanques G, Kwiatkoskwi F, Jaber S, Bazin JE. Intraoperative recruitment maneuver reverses detrimental pneumoperitoneum-induced respiratory effects in healthy weight and obese patients undergoing laparoscopy. Anesthesiology. 2010 Dec;113(6):1310-9. doi: 10.1097/ALN.0b013e3181fc640a.

    PubMed 21068660

  • Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.

    PubMed 19403595

  • Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.

    PubMed 19809292

  • Pelosi P, Ravagnan I, Giurati G, Panigada M, Bottino N, Tredici S, Eccher G, Gattinoni L. Positive end-expiratory pressure improves respiratory function in obese but not in normal subjects during anesthesia and paralysis. Anesthesiology. 1999 Nov;91(5):1221-31. doi: 10.1097/00000542-199911000-00011.

    PubMed 10551570

  • Tusman G, Bohm SH, Suarez-Sipmann F, Turchetto E. Alveolar recruitment improves ventilatory efficiency of the lungs during anesthesia. Can J Anaesth. 2004 Aug-Sep;51(7):723-7. doi: 10.1007/BF03018433.

    PubMed 15310643

  • Maisch S, Reissmann H, Fuellekrug B, Weismann D, Rutkowski T, Tusman G, Bohm SH. Compliance and dead space fraction indicate an optimal level of positive end-expiratory pressure after recruitment in anesthetized patients. Anesth Analg. 2008 Jan;106(1):175-81, table of contents. doi: 10.1213/01.ane.0000287684.74505.49.

    PubMed 18165575

  • Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.

    PubMed 19443420

  • Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005 Feb;100(2):580-584. doi: 10.1213/01.ANE.0000143339.40385.1B.

    PubMed 15673897

  • Hans GA, Sottiaux TM, Lamy ML, Joris JL. Ventilatory management during routine general anaesthesia. Eur J Anaesthesiol. 2009 Jan;26(1):1-8. doi: 10.1097/EJA.0b000e000000f1fb.

    PubMed 19122544

  • Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.

    PubMed 18270353

  • Gattinoni L, Carlesso E, Brazzi L, Caironi P. Positive end-expiratory pressure. Curr Opin Crit Care. 2010 Feb;16(1):39-44. doi: 10.1097/MCC.0b013e3283354723.

    PubMed 19996966

Questions about this trial

What is this clinical trial studying?

A study testing PEEP (positive end-expiratory pressure) in people with Bariatric Surgery, run by Brugmann University Hospital at 1 site in Belgium.

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 19 Jan 2018. 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 Belgium. 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.

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?

Number of hypoxemia episodes (Sp02<90%) (time frame: continuously during 48h after surgery). The study lists 2 primary outcomes in all. 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 NCT02579798, which also lists 16 linked publications.

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 19 Jan 2018.

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