NCT06551636

Brief Summary

One of the detrimental effects of invasive mechanical ventilation (IMV) is the alteration of the patient's mucociliary system that requires ventilatory support. The consequence of poor drainage of secretions, triggers secretion retention, atelectasis, and ventilator-associated pneumonia (VAP). Respiratory physiotherapy in the intubated patient facilitates the mobilization of retained and impacted secretions in the bronchial tree, decreasing resistance, improving lung compliance, and decreasing respiratory muscle work. The main objective of the present study is to measure the expiratory flow generated by the application of the DAA technique in the intubated patient during, after, at the end of the technique and at two hours. As secondary objectives, it is proposed to observe whether the application of the DAA maneuver in the patient with IMV improves oxygenation, produces changes in respiratory mechanics, improves air entrapment, decreases exhaled volume post DAA and analyzes the tolerance of DAA in IMV-conscious patients The study will be performed on patients admitted to the Intensive Care Unit (ICU) of the Parc Taulí University Hospital in Sabadell with IMV requirements. The intervention will consist of performing a respiratory physiotherapy session as usual in the daily clinical practice of the ICU, specifically the technique of assisted autogenous drainage, before, during and after the Better CareTM platform will be used to continuously record the physiological variables. necessary for the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

May 20, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

respiratory physiotherapyinvasive ventilationcritical care

Outcome Measures

Primary Outcomes (1)

  • To measure the expiratory flow in the intubated patient

    The following physiological variables will be obtained through the BC Link software using the services of the I3PT signal laboratory: final expiratory flow 25-75%(L/min)

    Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.

Secondary Outcomes (2)

  • To observe if the application of the AAD maneuver improves, produces changes in the respiratory mechanics; Compliance; Cst= Vt/Pplat-PEEP (ml/cmH2O)

    Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.

  • To observe if the application of the AAD maneuver improves, produces changes in the respiratory mechanics; Resistance R=Ppeak-Pplat/flow ( kPa x L-1 x sg)

    Data will be collected, 10 minutes (one hour before intervention), during 10 minutes (time of the respiratory physiotherapy session) and 10 min, two hours after therapy.

Interventions

The AAD technique involves placing the physiotherapist's hands on the chest where the secretions are identified and applying pressure to the chest. The maneuver will last according to the patient's tolerance, in an average of approximately 10 min.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects will be all patients over the age of 18 who are admitted to the ICU of the Parc Taulí University Hospital in Sabadell with IMV requirements

You may qualify if:

  • The subjects will be all patients over the age of 18 who are admitted to the ICU of the Parc Taulí University Hospital in Sabadell with IMV requirements
  • Subjects with hemodynamic stability; Higher mean blood pressure (PAM) 65 mmg, Heart rate (HR) less than 110 bpm and Oxygen saturation (SpO2) greater than 90% with or without norepinephrine \<0.5 mcg / Kg / min.

You may not qualify if:

  • patients with platelet pressures (Pm) greater than 30 cmH2O and / or expiratory pressure at the end of expiration (PEEP) ≥ 10cmH2O
  • patients who carriers of thoracic drainage
  • patients with costal and / or sternal fractures
  • pneumothorax
  • pregnant women
  • Obesity (BMI\> 35)
  • agitated patients with RASS greater than or equal to 3
  • patients with intracranial pressures greater than 20 cmH2O
  • dying.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (11)

  • Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41. doi: 10.1378/chest.105.1.237.

    PMID: 8275739BACKGROUND
  • Pneumatikos IA, Dragoumanis CK, Bouros DE. Ventilator-associated pneumonia or endotracheal tube-associated pneumonia? An approach to the pathogenesis and preventive strategies emphasizing the importance of endotracheal tube. Anesthesiology. 2009 Mar;110(3):673-80. doi: 10.1097/ALN.0b013e31819868e0.

    PMID: 19212256BACKGROUND
  • Pattanshetty RB, Gaude GS. Effect of multimodality chest physiotherapy on the rate of recovery and prevention of complications in patients with mechanical ventilation: a prospective study in medical and surgical intensive care units. Indian J Med Sci. 2011 May;65(5):175-85.

    PMID: 23364504BACKGROUND
  • Spapen HD, De Regt J, Honore PM. Chest physiotherapy in mechanically ventilated patients without pneumonia-a narrative review. J Thorac Dis. 2017 Jan;9(1):E44-E49. doi: 10.21037/jtd.2017.01.32.

    PMID: 28203436BACKGROUND
  • Branson RD. Secretion management in the mechanically ventilated patient. Respir Care. 2007 Oct;52(10):1328-42; discussion 1342-7.

    PMID: 17894902BACKGROUND
  • Volsko TA. Airway clearance therapy: finding the evidence. Respir Care. 2013 Oct;58(10):1669-78. doi: 10.4187/respcare.02590.

    PMID: 24064626BACKGROUND
  • Ambrosino N, Janah N, Vagheggini G. Physiotherapy in critically ill patients. Rev Port Pneumol. 2011 Nov-Dec;17(6):283-8. doi: 10.1016/j.rppneu.2011.06.004. Epub 2011 Jul 22.

    PMID: 21782380BACKGROUND
  • Calvo-Ayala E, Khan BA, Farber MO, Ely EW, Boustani MA. Interventions to improve the physical function of ICU survivors: a systematic review. Chest. 2013 Nov;144(5):1469-1480. doi: 10.1378/chest.13-0779.

    PMID: 23949645BACKGROUND
  • Guimaraes FS, Lopes AJ, Constantino SS, Lima JC, Canuto P, de Menezes SL. Expiratory rib cage Compression in mechanically ventilated subjects: a randomized crossover trial [corrected]. Respir Care. 2014 May;59(5):678-85. doi: 10.4187/respcare.02587. Epub 2013 Oct 8.

    PMID: 24106324BACKGROUND
  • Borges LF, Saraiva MS, Saraiva MAS, Macagnan FE, Kessler A. Expiratory rib cage compression in mechanically ventilated adults: systematic review with meta-analysis. Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):96-104. doi: 10.5935/0103-507X.20170014.

    PMID: 28444078BACKGROUND
  • Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.

    PMID: 18283429BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc PT

Study Record Dates

First Submitted

May 20, 2024

First Posted

August 13, 2024

Study Start

March 1, 2022

Primary Completion

November 1, 2023

Study Completion

April 1, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations