Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush)

NCT05668299 | Completed

• 1 other identifier: VEK protocol 76288
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Using a new device, the TrachFlush, the aim of this pilot study is to investigate whether secretions can be removed at the patient's current ventilator settings, or whether pressures and durations considered at the maximal end of clinical practice are required, so as to push secretions around the cuff. The study is a pilot study to investigate the settings required to ensure clinical efficacy of the technology, prior to large scale clinical studies.

Conditions

Mechanical Ventilation Complication; Intubation Complication

Keywords

Mechanical Ventilation; Suctioning; Critically ill patients; Secretion

Outcome Measures

Primary Outcomes (1)

• Ability to remove secretion from tube

  Success - clinical state is such that endotracheal suctioning is no longer required; Failure - clinical state has not improved sufficiently.

  Immediately after the procedure.

Secondary Outcomes (3)

• Procedures performed using increased settings.

  Immediately after the procedure

• Patient comfort

  Immediately after the procedure

• Hypoxia

  Immediately after the procedure

Study Arms (1)

TrachFlush group

EXPERIMENTAL

Patients in this arm received the intervention.

Device: TrachFlush

Interventions

TrachFlush DEVICE

See detailed description previously entered.

TrachFlush group

Eligibility Criteria

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

You may qualify if:

• Orally intubated and mechanically ventilated
• Patients for whom it is expected that secretions will be present during their ventilation period, as assessed by clinical evaluation.

You may not qualify if:

• Admission due to tracheal damage, e.g. inhalation trauma.
• Severe ARDS (acute respiratory distress syndrome), indicated by a PaO2/FiO2 ratio lower than 100 mmHg or PEEP \> 15 cmH2O.
• Circulatory instability indicated by use of vasopressor (Norepinephrine) \>0.1 micro gm/kg/min, heart rate \>120, arrhythmia other than atrial fibrillation.
• Patients with agitated delirium.
• Mechanical ventilation via tracheostomy
• Mechanical ventilation is provided with a mask or other non-invasive means
• Pregnancy

Sponsors & Collaborators

• Hospitalsenheden Vest: lead
• Viborg Regional Hospital: collaborator
• Herning Hospital: collaborator
• Aalborg University: collaborator

Study Sites (2)

Regional Hospital Herning

Herning, Central Jutland, 7400, Denmark

Location

Regional Hospital Viborg

Viborg, Central Jutland, 8800, Denmark

Location

Related Publications (8)

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  PMID: 2394120 BACKGROUND

• Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group. Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. doi: 10.1186/cc3026. Epub 2005 Jan 31.

  PMID: 15774056 BACKGROUND

• Maggiore SM, Lellouche F, Pignataro C, Girou E, Maitre B, Richard JC, Lemaire F, Brun-Buisson C, Brochard L. Decreasing the adverse effects of endotracheal suctioning during mechanical ventilation by changing practice. Respir Care. 2013 Oct;58(10):1588-97. doi: 10.4187/respcare.02265. Epub 2013 Mar 6.

  PMID: 23466423 BACKGROUND

• Efrati S, Deutsch I, Antonelli M, Hockey PM, Rozenblum R, Gurman GM. Ventilator-associated pneumonia: current status and future recommendations. J Clin Monit Comput. 2010 Apr;24(2):161-8. doi: 10.1007/s10877-010-9228-2. Epub 2010 Mar 17.

  PMID: 20237830 BACKGROUND

• Li J, Zong Y, Zhou Q, Dai H, Wang C. Evaluation of the Safety and Effectiveness of the Rapid Flow Expulsion Maneuver to Clear Subglottic Secretions in Vitro and in Vivo. Respir Care. 2017 Aug;62(8):1007-1013. doi: 10.4187/respcare.05348. Epub 2017 Apr 4.

  PMID: 28377403 BACKGROUND

• Zanella A, Florio G, Rezoagli E, Pastore M, Cadringer P, Biancolilli O, Carlesso E, Scaravilli V, Ristagno G, Pesenti AM. An Artificial Cough Maneuver to Remove Secretions From Below the Endotracheal Tube Cuff. Respir Care. 2019 Apr;64(4):372-383. doi: 10.4187/respcare.06076. Epub 2019 Jan 8.

  PMID: 30622174 BACKGROUND

• Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.

  PMID: 16823021 BACKGROUND

• Frandsen JB, O'Reilly Poulsen KS, Laerkner E, Stroem T. Validation of the Danish version of the Critical Care Pain Observation Tool. Acta Anaesthesiol Scand. 2016 Oct;60(9):1314-22. doi: 10.1111/aas.12770. Epub 2016 Jul 29.

  PMID: 27468726 BACKGROUND

Study Officials

• Nilanjan Dey, MD

  Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Model Details: Interventional, prospective, single arm study

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 29, 2022
• Study Start: October 1, 2021
• Primary Completion: February 8, 2022
• Study Completion: February 10, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)