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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03438383
Other study ID # 142/23-05-2011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2011
Est. completion date May 31, 2012

Study information

Verified date November 2020
Source Evangelismos Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.


Description:

In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias. The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 31, 2012
Est. primary completion date May 22, 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years - All patients had unsuccessfully tried to lose weight by other non-invasive means. - All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment - All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team - All patients were treated with the same standard anesthetic protocol Exclusion Criteria: - Cardiovascular and pulmonary disease not related to obesity status - Chronic renal disease - Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.

Study Design


Intervention

Device:
Bi-PAP
The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
Sham Bi-PAP
Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Evangelismos Hospital Elpis General Hospital, Evgenidion Hospital, Sotiria General Hospital

References & Publications (40)

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Wong DT, Adly E, Ip HY, Thapar S, Maxted GR, Chung FF. A comparison between the Boussignac™ continuous positive airway pressure mask and the venturi mask in terms of improvement in the PaO2/F(I)O2 ratio in morbidly obese patients undergoing bariatric surgery: a randomized controlled trial. Can J Anaesth. 2011 Jun;58(6):532-9. doi: 10.1007/s12630-011-9497-3. Epub 2011 Apr 5. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume at One Second (FEV1) Difference difference in FEV1 value measured by spirometry pre- and post-operatively 24 h before surgery and at 24, 48 and 72 h post-operatively
Primary Forced Vital Capacity (FVC) Difference difference in FVC value measured by spirometry pre- and post-operatively 24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary Peak Expiratory Flow Rate (PEFR) Difference difference in PEFR value measured by spirometry pre- and post-operatively 24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary SpO2 Difference difference in SpO2 value measured by spirometry pre- and post-operatively 24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary Number of Participants With Hypoxemia occurrence of hypoxemia, considered as SpO2<90%, post-operatively At 24, 48 and 72 hours post-operatively
Primary Number of Participants With Atelectasis occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline At 24, 48 and 72 hours post-operatively
Secondary Post-operative Pain Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable) right before spirometry, at 24, 48 and 72 h post-operatively
Secondary Days of Hospitalization duration of hospitalization, calculated by discharge date minus admission date From day of admission to day of discharge from the hospital
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