Esophageal Balloon Calibration in Assisted Ventilation Mode

NCT03721237 | Completed

• 1 other identifier: CE 111/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Mechanical Ventilation Pressure High

Keywords

Esophageal catheter calibration; Assisted mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• Effects of ventilatory mode on calibrated esophageal ballon best volume

  Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes

  Over 120 minutes in PSV

• Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh

  Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh

  Over 30 minutes in PSV + Sigh

Secondary Outcomes (3)

• Changes of respiratory mechanics indices in PSV

  over 30 minutes in PSV

• Changes of respiratory mechanics indices in PSV + sigh

  over 30 minutes in PSV + Sigh

• Gas exchange

  over 30 minutes during each trial

Study Arms (1)

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.

Other: EBC-assisted

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).

EBC-assisted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

A.O.U Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (9)

• Pelosi P, Bottino N, Chiumello D, Caironi P, Panigada M, Gamberoni C, Colombo G, Bigatello LM, Gattinoni L. Sigh in supine and prone position during acute respiratory distress syndrome. Am J Respir Crit Care Med. 2003 Feb 15;167(4):521-7. doi: 10.1164/rccm.200203-198OC. Epub 2002 Dec 18.

  PMID: 12493644 BACKGROUND

• Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94. doi: 10.1097/00000542-200204000-00004.

  PMID: 11964584 BACKGROUND

• Ranieri VM, Brienza N, Santostasi S, Puntillo F, Mascia L, Vitale N, Giuliani R, Memeo V, Bruno F, Fiore T, Brienza A, Slutsky AS. Impairment of lung and chest wall mechanics in patients with acute respiratory distress syndrome: role of abdominal distension. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1082-91. doi: 10.1164/ajrccm.156.4.97-01052.

  PMID: 9351606 BACKGROUND

• Gattinoni L, Chiumello D, Carlesso E, Valenza F. Bench-to-bedside review: chest wall elastance in acute lung injury/acute respiratory distress syndrome patients. Crit Care. 2004 Oct;8(5):350-5. doi: 10.1186/cc2854. Epub 2004 May 7.

  PMID: 15469597 BACKGROUND

• Talmor D, Sarge T, O'Donnell CR, Ritz R, Malhotra A, Lisbon A, Loring SH. Esophageal and transpulmonary pressures in acute respiratory failure. Crit Care Med. 2006 May;34(5):1389-94. doi: 10.1097/01.CCM.0000215515.49001.A2.

  PMID: 16540960 BACKGROUND

• Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.

  PMID: 7149443 BACKGROUND

• Bellani G, Grasselli G, Teggia-Droghi M, Mauri T, Coppadoro A, Brochard L, Pesenti A. Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study. Crit Care. 2016 Apr 28;20(1):142. doi: 10.1186/s13054-016-1290-9.

  PMID: 27160458 BACKGROUND

• Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.

  PMID: 27063290 BACKGROUND

• Mauri T, Cambiaghi B, Spinelli E, Langer T, Grasselli G. Spontaneous breathing: a double-edged sword to handle with care. Ann Transl Med. 2017 Jul;5(14):292. doi: 10.21037/atm.2017.06.55.

  PMID: 28828367 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Gianmaria Cammarota, MD,PhD

  "Maggiore della Carità" Hospital, Novara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in staff of the ICU

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 26, 2018
• Study Start: November 15, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2018-12

Locations

IT (1)