Abdominal Pressure Assessment Following Open Abdominal Surgery (AbdoPress)

November 4, 2020 updated by: Paolo Navalesi, University Magna Graecia

Evaluation of the Abdominal Pressure Modifications in Patients Undergone to Open Abdominal Surgery and Receiving Continuous Positive Airway Pressure

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Catanzaro, Italy
        • Recruiting
        • Magna Graecia University - University Hospital Mater Domini
        • Contact:
          • Paolo Navalesi, MD
      • Ferrara, Italy
        • Recruiting
        • Dipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Sezione di Anestesiologia e Terapia Intensiva Universitaria, Università degli studi di Ferrara
        • Contact:
          • Savino Spadaro, MD
      • Pavia, Italy
        • Recruiting
        • Department of Anesthesia and Intensive Care, IRCCS Policlinic San Matteo Hospital Foundation , Pavia , Italy
        • Contact:
          • Silvia Poma
      • Roma, Italy
        • Recruiting
        • Anesthesia and Intensive Care Medicine, Sapienza University of Rome, Policlinico Umberto I Hospital
        • Contact:
          • Francesco Alessandri
      • Sassari, Italy
        • Recruiting
        • University of Sassari
        • Contact:
          • Paolo Terragni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will observe the aforementioned physiologic parameters in 100 patients randomized to receive CPAP treatment in another international multicenter trial (PRISM trial). Patients will be therefore eligible if 50 years old or higher, undergoing major, open, intra-peritoneal surgery.

Description

Inclusion Criteria:

  • Patients aged 50 years or over undergoing major, open, intra-peritoneal surgery, randomized to receive Continuous Positive Airway Pressure in the "Prevention of Respiratory Insufficiency after Surgical Management (P.R.I.S.M. TRIAL)"

Exclusion Criteria:

  • Inability or refusal to provide informed consent
  • Anticipated requirement for invasive or non-invasive mechanical ventilation for at least four hours after surgery as part of routine care
  • Pregnancy or obstetric surgery
  • Previous enrollment in PRISM trial
  • Participation in a clinical trial of a treatment with a similar biological mechanism or related primary outcome measure
  • Clinician refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CPAP
At the end of the abdominal surgical procedure, mechanical ventilation withdrawal and extubation, patients will receive Continuous Positive Airway Pressure CPAP). CPAP will be be delivered using any commercially available CPAP equipment. CPAP will be started as soon as possible after the end of surgery. The starting airway pressure (PEEP) will be 5 cmH2O. PEEP may be changed at the discretion of the responsible physician. The maximum permissible PEEP during the trial intervention period will be 10 cmH2O. CPAP may be continued after the four-hour trial intervention period has finished, at the discretion of the responsible physician.
Other: Abdominal pressure assessment
We will perform measurements of the abdominal pressure an urinary catheter connected with an intra-abdominal pressure device (Uno-Meter ® - Unomedical) in all patients undergoing on open-surgical procedures after mechanical ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominal pressure in post-surgical patients (abdominal open surgery procedures)
Time Frame: Within 30 minutes by the end of surgery and mechanical ventilation withdrawn
Assessment of abdominal pressure through a dedicated device connected to the urinary catheter
Within 30 minutes by the end of surgery and mechanical ventilation withdrawn

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Abdominal pressure
Time Frame: After 30 minutes from the application of Continuous Positive Airway Pressure
Assessment of abdominal pressure through a dedicated device connected to the urinary catheter
After 30 minutes from the application of Continuous Positive Airway Pressure
Abdominal pressure
Time Frame: After 4 hours from the application of Continuous Positive Airway Pressure
Assessment of abdominal pressure through a dedicated device connected to the urinary catheter
After 4 hours from the application of Continuous Positive Airway Pressure
Arterial blood gases
Time Frame: Within 30 minutes by the end of surgery and mechanical ventilation withdrawn
Sample of arterial blood for gas analysis
Within 30 minutes by the end of surgery and mechanical ventilation withdrawn
Arterial blood gases
Time Frame: After 30 minutes from the application of Continuous Positive Airway Pressure
Sample of arterial blood for gas analysis
After 30 minutes from the application of Continuous Positive Airway Pressure
Arterial blood gases
Time Frame: After 4 hours from the application of Continuous Positive Airway Pressure
Sample of arterial blood for gas analysis
After 4 hours from the application of Continuous Positive Airway Pressure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Magna Graecia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paolo Navalesi, MD, Magna Graecia University, Catanzaro, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 284/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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