NCT03398239

Brief Summary

The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

November 30, 2016

Last Update Submit

January 7, 2018

Conditions

Hypercapnic Respiratory Failure

Keywords

respiratory failure, hypercapnia, BPAP, AVAPS

Outcome Measures

Primary Outcomes (1)

  • PaCO2 values

    Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS

    On arrival, at one hour, and at two hourly intervals thereafter

Secondary Outcomes (3)

  • Failure of treatment options

    During the treatment

  • Length of hospital stay

    up to 6 months

  • The time of treatment

    During the treatment

Study Arms (2)

BPAP ST/T

ACTIVE COMPARATOR

Non-invasive Ventilation with BPAP ST/T mode

Device: Noninvasive mechanical ventilation

AVAPS

EXPERIMENTAL

Non-invasive Ventilation with AVAPS mode

Device: Noninvasive mechanical ventilation

Interventions

Noninvasive mechanical ventilationDEVICE
AVAPSBPAP ST/T

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PaCO2 \> 45mmHg and any of the following
  • SaO2 \<90% on air
  • SaO2 \<93% on \>6 Litres O2/min
  • Inability to speak in sentences due to respiratory distress
  • Respiratory rate \> 24/min
  • Altered mental status
  • The use of accessory muscles of respiration

You may not qualify if:

  • Respiratory arrest or unstable cardiorespiratory status
  • Suspected Pneumothorax
  • Urgent need for intubation
  • Systolic blood pressure \< 90 mmHg
  • Inability to protect airway
  • Facial deformity
  • Facial, esophageal, or gastric surgery history
  • All trauma patients
  • Acute myocardial infarction
  • Severe arrythmias
  • Refractory nausea and vomiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory InsufficiencyHypercapnia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Başak Bayram, MD

    Dokuz Eylul University, School of Medicine, Department of Emergency Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

November 30, 2016

First Posted

January 12, 2018

Study Start

October 20, 2016

Primary Completion

July 20, 2017

Study Completion

August 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

TU(1)