Lung Overdistension and Abdominal Pressure Rise

NCT ID: NCT06174636

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2025-06-30

Brief Summary

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The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.

Detailed Description

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Conditions

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Respiratory Failure Respiratory Distress Syndrome, Adult

Keywords

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Abdominal pressure Overdistension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abdominal Pressure Rise

Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data

Group Type EXPERIMENTAL

Application of abdominal weight

Intervention Type PROCEDURE

Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP

Interventions

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Application of abdominal weight

Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP

Intervention Type PROCEDURE

Other Intervention Names

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Intra abdominal pressure rise

Eligibility Criteria

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Inclusion Criteria

* Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 \<300 mmHg)
* Need of PEEP trial
* Need of urinary catheter (used to measure IAP)

Exclusion Criteria

* Contraindication to EIT use
* Pacemaker or other metal device in thoracic region
* Contraindication to abdominal weight placement
* Surgical or traumatic incision on the abdomen
* Severe abdominal hypertension
* Esophageal diseases that counterindicate naso-gastric tube placement
* Severe hemodynamic instability (norepinephrine \> 0.1 mcg/kg/min; dobutamine or dopamine \> 5 mcg/kg/min; epinephrine every dosage)
* Severe obesity (BMI \> 35 kg/m2)
* Need of \> 7 kg weight to reach 5 mmHg IAP increase
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Paolo Persona

Medical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Università di Padova

Padua, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Persona, MD, PhD

Role: CONTACT

Phone: +39 3389745902

Email: [email protected]

Facility Contacts

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Paolo Persona, MD

Role: primary

References

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Pacchiarini G, Pettenuzzo T, Zarantonello F, Sella N, Lumetti G, Boscolo A, De Cassai A, Cammarota G, Persona P, Navalesi P; LOVE BEER Study Group. The "mechanical paradox" unveiled: a physiological study. Crit Care. 2025 May 16;29(1):194. doi: 10.1186/s13054-025-05385-9.

Reference Type DERIVED
PMID: 40380228 (View on PubMed)

Other Identifiers

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AOP2978

Identifier Type: -

Identifier Source: org_study_id