Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03369483 |
| Other study ID # |
284/2017 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2018 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
University Magna Graecia |
| Contact |
Paolo Navalesi, MD |
| Phone |
+393355321910 |
| Email |
pnavalesi[@]unicz.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
During abdominal surgery, the intra abdominal pressure may increase determining lung bibasal
atelectasis. The investigators hypothesized that the application of Positive End Expiratory
Pressure (PEEP) promptly after extubation through Continuous Positive Airway Pressure (CPAP)
would improved gas exchange, especially in those patients with abdominal pressure values
close to those applied by CPAP.
The investigators have therefore designed this subset study enrolling patients randomized to
receive CPAP in the "Prevention of Respiratory Insufficiency after Surgical Management
(PRISM)" Trial in order to ascertain the abdominal pressure in post-surgical patients
(abdominal open surgery procedures) enrolled in PRISM trial. In addition they would evaluate
the effects of CPAP on abdominal pressure and consequently on arterial blood gas, and whether
there is a correlation between PEEP values, abdominal pressure values and arterial blood gas.
One hundred patients included in CPAP group of the PRISM trial will be enrolled in this
subset study. The investigators will perform measurements of the abdominal pressure an
urinary catheter connected with an intra-abdominal pressure device (Uno-Meter ® -
Uno-medical) in all patients undergoing on open-surgical procedures after mechanical
ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.
Description:
Major abdominal surgery is associated with adverse changes in respiratory function.
Anaesthesia can cause reduced vital capacity, hypoxaemia and impaired central respiratory
drive, while surgical manipulation can restrict ventilation, damage the respiratory muscles
and cause atelectasis. These factors interact with pre-existing respiratory disease and
postoperative pain to create a significant risk of pneumonia and respiratory failure, which
may result in death. Evidence from one study suggests that the risk of mortality within 30
days of surgery is increased from 1% to 27% in patients with respiratory failure. Usual
treatments including supplemental oxygen or respiratory physiotherapy may not always prevent
deterioration in respiratory function. Subsequent respiratory failure can lead to
endotracheal intubation and mechanical ventilation, which is in turn associated with a range
of serious morbidities. Continuous positive airway pressure (CPAP) is a non-invasive method
of supporting respiratory function. The patient breathes through a pressurized circuit
against a threshold resistor that maintains a pre-set positive airway pressure during both
inspiration and expiration. The findings of several trials have demonstrated the efficacy of
CPAP as preventative treatment for high-risk patients following abdominal surgery by reducing
the incidence postoperative pulmonary complications.
The investigators have hypothesized that the application of Positive End Expiratory Pressure
(PEEP) promptly after extubation through CPAP would improved gas exchange, especially in
those patients with abdominal pressure values close to those applied by CPAP.
The investigators have therefore designed this subset study enrolling patients randomized to
receive CPAP in the "Prevention of Respiratory Insufficiency after Surgical Management
(PRISM)" Trial in order to ascertain the abdominal pressure in post-surgical patients
(abdominal open surgery procedures) enrolled in PRISM trial. In addition they would evaluate
the effects of CPAP on abdominal pressure and consequently on arterial blood gas, and whether
there is a correlation between PEEP values, abdominal pressure values and arterial blood gas.
One hundred patients included in CPAP group of the PRISM trial will be enrolled in this
subset study. To be included in the PRISM trial, patients are required to be 50 years/old or
over and to undergo major, open, intra-peritoneal surgery. Patients are excluded of meeting
one or more of the following: 1) inability or refusal to provide informed consent; 2)
anticipated requirement for invasive or non-invasive mechanical ventilation or at least four
hours after surgery as part of routine care; 3) pregnancy or obstetric surgery; 4) previous
enrolment in PRISM trial; 5) participation in a clinical trial of a treatment with a similar
biological; 6) mechanism or related primary outcome measure and 7) clinician refusal.
CPAP will be provided for at least four hours, with minimal interruption, started soon after
the patient has left the operating room after surgery. Administration of CPAP will only take
place under the direct supervision of appropriately trained staff in an adequately equipped
clinical area. The monitoring of patients receiving CPAP will be in accordance with local
hospital policy or guidelines. Alterations to the administered dose will be recorded along
with the reason for this change. Clinicians may only use commercially available CPAP
equipment to deliver the intervention. The starting airway pressure should be 5 cmH2O and the
maximal permissible airway pressure is 10 cmH2O.
The investigators will perform measurements of the abdominal pressure an urinary catheter
connected with an intra-abdominal pressure device (Uno-Meter ® - Uno-medical) in all patients
undergoing on open-surgical procedures after mechanical ventilation withdrawal and
extubation, 30 minutes and 4 hours after the application of CPAP. Moreover, arterial blood
will be sample for gas analysis at every aforementioned time-step.
