PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure

NCT02056977 | Unknown

• 1 other identifier: 513.205
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

• Compare PEEP level selected by individualized PEEP titration by electrical impedance tomography and PEEP level routinely used in post-operative cardiac patients with Hypoxemic Respiratory Failure;
• Evaluate the agreement between the results of a rapid titration (total procedure duration = 5 min) versus an already validated slow titration (total procedure duration = 40 min) of the same patient, sequentially. Specifically, degree of collapse and degree of distention in each PEEP level, estimated by EIT;
• Compare hemodynamics during the two maneuvers of PEEP titration;
• Evaluate the efficacy of the selected PEEP (minimum PEEP preventing lung collapse less than 5%) to maintain stable levels of the following variables: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT;
• Compare these results (evolution of the three variables, along 4 hours) with the control strategy (default strategy currently used in the institution) group.

Conditions

Post Operative Cardiac Surgery; ARDS; Hypoxemic Respiratory Failure

Keywords

Acute Respiratory Distress Syndrome; Cardiac Surgical Procedure; Mechanical Ventilation; Postoperative Complications; Positive End-Expiratory Pressure; Lung Collapse; Respiratory Failure; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver.

  Evaluate the agreement between the ideal PEEP determined by the rapid PEEP titration maneuver versus the ideal PEEP determined by the slow PEEP titration maneuver. The degree of collapse and overdistention at each PEEP level, as estimated by EIT, will be also compared during both procedures. Ideal PEEP is the minimum PEEP capable of keeping collapse at \< 5%.

  2 hours

Secondary Outcomes (1)

• Stability of the selected PEEP according to the rapid titration in arterial oxygenation (SpO2, in %), respiratory system compliance (in cmH2O), and degree of collapse by EIT (in %)

  4 hours

Other Outcomes (1)

• Comparison of the PEEP levels selected by the proposed strategy (rapid titration maneuver) and the PEEP levels used in the control group.

  4 hours

Study Arms (2)

Titration

EXPERIMENTAL

Individualized PEEP titration by EIT

Other: Titration

Control

ACTIVE COMPARATOR

PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio)

Other: control

Interventions

Titration OTHER

Individualized PEEP according to PEEP titration monitored by EIT

Also known as: Individualized PEEP

Titration

control OTHER

PEEP selected according to a PaO2/FIO2 table as in the routines of the institution

Also known as: Control PEEP

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
• Acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2) no \>200 mmHg and bilateral pulmonary infiltrates on XRay consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary capillary wedge pressure \<18 mmHg, when available).
• Age \> 18 and \< 70 years old
• Absence previous pulmonary disease
• Left ventricular ejection fraction \> 35%
• Absence of previous cardiac surgery and / or lung disease;
• Not requiring adjusted volume expansion (pulse pressure delta \<13% or legs raising test without hemodynamic changes in cardiac index or mean arterial pressure).
• Body mass index \< 40 kg/m2
• Written inform consent

You may not qualify if:

• MAP \< 70 mmHg
• Noradrenaline \> 1 micrograms/Kg/min
• Acute arrhythmias
• Blooding associated to hemodynamic instability
• Need of re-surgery and/or mechanical circulatory assistance
• Suspicion of neurological alteration
• Chest tube with persistent air leak

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Financiadora de Estudos e Projetos: collaborator

Study Sites (1)

USP Instituto do Coração

São Paulo, 05.403-010, Brazil

RECRUITING

Related Publications (1)

• Costa EL, Amato M. Hemodynamic and respiratory changes during lung recruitment and descending optimal positive end-expiratory pressure titration with acute respiratory distress syndrome. Crit Care Med. 2007 Aug;35(8):1998-9; author reply 1999. doi: 10.1097/01.ccm.0000277060.87425.6b. No abstract available.

  PMID: 17667256 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Postoperative Complications; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcelo BP Amato

  Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo BP Amato

CONTACT

3061-7361; marcelo.amato@limpneumo.fm.usp.br

Maria AM Nakamura

CONTACT

3061-7361; mamiyukinakamura@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 6, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

BR (1)