---
title: Esophageal Balloon Calibration in Assisted Ventilation Mode
nct_id: NCT03721237
overall_status: COMPLETED
phase: NA
sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
study_type: INTERVENTIONAL
primary_condition: Respiratory Failure
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03721237.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03721237"
ct_last_update_post_date: 2019-09-04
last_seen_at: "2026-05-12T07:12:24.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Esophageal Balloon Calibration in Assisted Ventilation Mode

**Official Title:** Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study

**NCT ID:** [NCT03721237](https://clinicaltrials.gov/study/NCT03721237)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Azienda Ospedaliero Universitaria Maggiore della Carita
- **Conditions:** Respiratory Failure, Mechanical Ventilation Pressure High
- **Start Date:** 2018-11-15
- **Completion Date:** 2019-08-01
- **CT.gov Last Update:** 2019-09-04

## Brief Summary

Esophageal balloon calibration (EBC) has been proposed during controlled mechanical ventilation in intubated patients in order to optimize esophageal pressure (Pes) signal. Actually, at our knowledge, no data exist about EBC during assisted ventilatory modes such as Pressure Support Ventilation (PSV). The primary endpoint of the present investigation is to assess the feasibility of EBC during PSV and PSV plus Sigh.

## Detailed Description

Assisted ventilatory modes, nowadays, have been proved to reduce complications related to controlled mechanical ventilation. With these modes, ventilatory cycling is under the patient's control to an extent depending on the type of ventilatory modality.

Sigh improves oxygenation and lung mechanics during pressure control ventilation and pressure support ventilation (PSV) in patients with acute respiratory distress syndrome.

In order to better quantify the effects of both PSV and PSV plus Sigh on respiratory mechanics, the esophageal pressure monitoring could be helpful. However, esophageal pressure (Pes) assessment requires esophageal ballon calibration (EBC) as demonstrated in intubated patients under controlled mechanical ventilation.

At our knowledge, no data exist about EBC during assisted ventilatory modes. The primary aim of the present study is to evaluate the effects of PSV and PSV plus Sigh ventilation on esophageal balloon best volume in patients admitted to the intensive care unit for acute respiratory failure.

.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* patients older than 18 years;
* undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation;

Exclusion Criteria:

* severe COPD with air trapping clinical suspicion;
* hemodynamic instability requiring inotropic or vasopressor support;
* any contraindications to esophageal catheter positioning
```

## Arms

- **EBC-assisted** (EXPERIMENTAL) — A nasogastric tube, equipped with esophageal and gastric balloons, will be inserted in each patient enrolled in the study. After definitive catheter positioning has been obtained, Esophageal ballon calibration will be run in volume-controlled ventilation, pressure support ventilation and sigh + pressure support ventilation.

## Interventions

- **EBC-assisted** (OTHER) — After definitive catheter positioning, esophageal balloon calibration will be performed in:

1. volume-controlled mode with tidal volume set to obtain 6-8 lm/kg of ideal body weight (reference),
2. pressure support ventilation (PSV) with support set to obtain a tidal volume ranging between 6-8 ml/kg of ideal body weight at equal PEEP of volume control mode (PSV baseline);
3. PSV + sigh ventilation (sigh setting: total inspiratory pressure equal to 35 cmH2O at a rate of 1/ minute; inspiratory time equal to 4 seconds).

## Primary Outcomes

- **Effects of ventilatory mode on calibrated esophageal ballon best volume** _(time frame: Over 120 minutes in PSV)_ — Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes
- **Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh** _(time frame: Over 30 minutes in PSV + Sigh)_ — Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh

## Secondary Outcomes

- **Changes of respiratory mechanics indices in PSV** _(time frame: over 30 minutes in PSV)_
- **Changes of respiratory mechanics indices in PSV + sigh** _(time frame: over 30 minutes in PSV + Sigh)_
- **Gas exchange** _(time frame: over 30 minutes during each trial)_

## Locations (1)

- A.O.U Maggiore della Carità, Novara, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.a.o.u maggiore della carità|novara||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03721237.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03721237*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*