Condition category
Circulatory System
Date applied
06/07/2017
Date assigned
19/07/2017
Last edited
26/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute respiratory failure occurs when the lungs are unable to remove the carbon dioxide from the lungs. This can be caused by a variety of lung issues such as chronic obstructive pulmonary disease (COPD) (causes the airways to be narrowed), asthma (difficulty breathing), pneumonia (swelling of the lungs), acute respiratory distress syndrome (ARDs) (when fluid buildings up in the lungs), congestive heart failure and interstitial lung disease (diseases affecting the tissue and space around the air sacs of the lungs). The usually treatment is to provide helping breathing. Noninvasive ventilation is a type of breathing support that involves the patient wearing a face mask during sleep which is connected to the machine that supplies a constant steam of pressurised air to help keep the airways open. The settings of the noninvasive ventilation are determined based on clinical evaluation, blood gas, volumes, flow and pressure. This is usually done individually and is different for patients. Having a fixed and preprogrammed setting that is kept constant could be helpful, such as using a BIPAP S/T AVAPS strategy. The aim of this study is to evaluate the results of using the ventilator strategy on patients with acute respiratory failure due to different reasons.

Who can participate?
Adults aged 18 and older with acute respiratory failure.

What does the study involve?
Participants are allocated based on their reason for acute respiratory failure. They are then given the BIPAP S/T AVAPS strategy. This is initially programmed to provide maximal inspiratory positive pressure of 20 cm and a minimum of 12 cm with a positive expiratory pressure of 6-8 cm. Participants are followed up to measure the blood gas levels, severity of diseases, blood pressure, heart rate, respiratory rate and other breathing measures.

What are the possible benefits and risks of participating?
Participants may benefit from using the non-invasive ventilation such as the use of additional medication (sedation) and a not having a tube in the mouth. There are risks of complications with the mask and airway pressures.

Where is the study run from?
Universidad de Guayaquil (Ecuador)

When is the study starting and how long is it expected to run for?
December 2011 to January 2014

Who is funding the study?
1. Universidad San Francisco de Quito (Ecuador)
2. Universidad San Francisco de Quito (Ecuador)
3. Santa Maria Clinic (Ecuador)

Who is the main contact?
1. Dr Killen Briones Claudett
killen.brionesc@ug.edu.ec
2. Dr Michelle Grunauer
mgrunauer@usfq.edu.ec

Trial website

Contact information

Type

Scientific

Primary contact

Prof Killen Harold Briones Claudett

ORCID ID

http://orcid.org/0000-0002-7778-0362

Contact details

The University of Guayaquil (Universidad de Guayaquil)
Facultad de Ciencias Médicas
Av. Kennedy y Av. Delta
Guayaquil
090514
Ecuador

Type

Scientific

Additional contact

Dr Michelle Grunauer

ORCID ID

http://orcid.org/0000-0002-5821-7603

Contact details

Av. Interoceánica Km 12 ½ Edificio de Especialidades Médicas PB Hospital de los Valles
Universidad San Francisco de Quito
Quito
-
Ecuador
+593 (0)9 98938210
mgrunauer@usfq.edu.ec

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2011.14 (1)

Study information

Scientific title

Non-Invasive mechanical Ventilation with pressure support guaranteed with average volume (AVAPS) in Acute Respiratory Failure of various etiologies

Acronym

NIV and AVAPS

Study hypothesis

The aim of this study is to evaluate if the ventilatory strategy useful in patients with acute respiratory failure of various etiologies.

Ethics approval

Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (1)

Study design

Single-center retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

The patients were divided according to the pathology on the basis of which presented the acute respiratory failure: COPD / bronchial asthma / pneumonia / ARDS / congestive heart failure and interstitial disease

Intervention

Participants are allocated to groups based on their type of acute respiratory failure:

Hypercapnic ARF: Obstructive diseases (COPD and bronchial asthma)
Hypoxemic ARF: Pneumonia, ARDS, congestive heart failure, and intestitial lung disease

Participants are then given BiPaP S/T +AVAPS therapy. The ventilatory parameters are initially programmed in the BiPAP S/T mode with AVAPS with a maximal inspiratory positive pressure (IPAP) programmed in the 20 cm H2O device and a minimum programmed IPAP of 12 cm H2O with a positive expiratory pressure (EPAP) of 6-8 cm water.

The programmed tidal volume is 6-8 ml/kg of ideal body weight, using the following formula 55.5 ± 2.3 (inches-60) for men and 45.5 for women + 2.3 (inches) 60) respiratory rate was 14-20 breaths/min, rise time 300-400 ms and inspiratory time was 0.8 - 1.2s. Oxygen supplements are added through an oxygen adapter close to the mask, to keep the SaO2 above 90%. Maximum IPAP, exhaled tidal volume (Vt exh), Vmin and leaks arecontrolled through the ventilator software. This is done using the BiPAP Synchrony with AVAPS and Autotrak (Respironics Inc., Murrysville, Pennsylvania, USA) and a series of Mirage IV (Resmed) face masks.

Participants are followed up to measure the blood gas levels, severity of diseases, blood pressure, heart rate, respiratory rate and other breathing measures.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Use of NIV is measured using patient records at discharge from hospital
2. Aterial blood gas is measured using an arterial blood gas test (blood test) at baseline, one, 12 and 24 hours of NIV use
3. Severity of disease is measured using the APACHE II (Acute Physiology and Chronic Health Evaluation (APACHE II ) score at range (0-71 points)
4. Blood pressure (mm/Hg) is measured using a blood pressure cuff
5. Heart rate is measured using pulse monitors
6. Respiratory rate is measured using the amount of breaths over one minute.
7. Tidal volume (mL) programmed AVAPs is measured using patient records.
8. Levels of IPAP (cmH2O) are measured using patient records
9. Level of EPAP (cmH2O) are measured using patient records
10. Inspiratory time (mseg) is measured using patient records
11. Tidal volume patients (mL) is measured using patient records
12. Radiographic changes are measured at number quadrant divided into four according to the affection
13. Complications (excessive discomfort, nasal ulcer, gastric distension and claustrophobia) are measured using patient records

Secondary outcome measures

1. Days of hospitalisation is measured using patient records at number of discharge
2. Number of endotrachael intubation is measured using patient records at number of intubated patients and their percentage at discharge
3. Death is measured using patient records at time of death

Overall trial start date

01/07/2010

Overall trial end date

01/01/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Admitted to the intensive care unit of Santa Maria Clinic
3. Acute respiratory failure due to exacerbation of COPD, asthma, pneumonia, ARDS, congestive heart failure and intestitial lung disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant exclusion criteria

1. Facial deformity
2. Obstruction of the upper airway by surgery or trauma
3. Alterations in the central nervous system does not relating to hypercapnic encephalopathy
4. Cardiogenic pulmonary edema, pulmonary embolism, pneumothorax, hemoptysis, or septic shock
5. Urgent intubation due to cardiorespiratory arrest and hemodynamic instability with systolic pressure less than 80 mm Hg. 6. Hemodynamic instability
7. Excess of respiratory secretions
8. Non-cooperative or agitated
9. Unable to use the interface device
10. Has had recent surgery of the upper airway,
11. Received NIV with “Do not resuscitate orders"

Recruitment start date

01/12/2010

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Ecuador

Trial participating centre

Universidad de Guayaquil
Ciudadela Universitaria
Guayaquil
5934
Ecuador

Trial participating centre

Universidad San Francisco de Quito
School of Medicine Valle de Cumbaya
Quito
5932
Ecuador

Trial participating centre

Santa Maria Clinic
Intensive Care Unit Lorenzo de Garaycoa 3209 y Argentina
Guayaquil
5934
Ecuador

Sponsor information

Organisation

The University of Guayaquil (Universidad de Guayaquil)

Sponsor details

Ciudadela Universitaria
Facultad de Ciencias Médicas
Av. Kennedy y Av. Delta
Guayaquil
5934
Ecuador

Sponsor type

University/education

Website

https://servicioenlinea.ug.edu.ec/siug/

Organisation

Universidad San Francisco de Quito

Sponsor details

School of Medicine
Valle de los Chillos en Cumbaya
Diego de Robles y Vía Interoceánica
Quito
090514
Ecuador

Sponsor type

University/education

Website

http://www.usfq.edu.ec

Funders

Funder type

University/education

Funder name

Universidad San Francisco de Quito

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Killen Briones Claudett (kyllenbrio@yahoo.com).

Intention to publish date

01/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/07/2017: Added new contact.