Abdominal Pressure Assessment Following Open Abdominal Surgery

NCT03369483 | Unknown

• 1 other identifier: 284/2017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Lung Collapse

Outcome Measures

Primary Outcomes (1)

• Abdominal pressure in post-surgical patients (abdominal open surgery procedures)

  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  Within 30 minutes by the end of surgery and mechanical ventilation withdrawn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 Outcomes (5)

• Abdominal pressure

  After 30 minutes from the application of Continuous Positive Airway Pressure

• Abdominal pressure

  After 4 hours from the application of Continuous Positive Airway Pressure

• Arterial blood gases

  Within 30 minutes by the end of surgery and mechanical ventilation withdrawn

• Arterial blood gases

  After 30 minutes from the application of Continuous Positive Airway Pressure

• Arterial blood gases

  After 4 hours from the application of Continuous Positive Airway Pressure

Study Arms (1)

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

Interventions

Abdominal pressure assessment OTHER

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.

CPAP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)"

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (5)

Magna Graecia University - University Hospital Mater Domini

Catanzaro, Italy

RECRUITING

Dipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Sezione di Anestesiologia e Terapia Intensiva Universitaria, Università degli studi di Ferrara

Ferrara, Italy

RECRUITING

Department of Anesthesia and Intensive Care, IRCCS Policlinic San Matteo Hospital Foundation , Pavia , Italy

Pavia, Italy

RECRUITING

Anesthesia and Intensive Care Medicine, Sapienza University of Rome, Policlinico Umberto I Hospital

Roma, Italy

RECRUITING

University of Sassari

Sassari, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paolo Navalesi, MD

  Magna Graecia University, Catanzaro, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Navalesi, MD

CONTACT

+393355321910; pnavalesi@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: March 13, 2018
• Primary Completion: March 5, 2021
• Study Completion: March 31, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

IT (5)