Respiratory PhysiotherapyNCT06551636
Effects on the Expiratory Flow of AAD in a Critical Patient With IMV
An observational study of Respiratory Physiotherapy, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Physiotherapy
- What is being tested?
- respiratory physiotherapy (AAD)
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- agitated patients with RASS greater than or equal to 3
- patients with intracranial pressures greater than 20 cmH2O
- dying.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on the Expiratoriy Flow of Assisted Autogen Drainage in a Critical Patient Wtih Invasive Mechanical Ventilation
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.
Read the detailed description
Ventilated air blown into the bronchial shaft through the orotracheal tube (OT) causes ciliary dyskinesia by decreasing the rate of progression of secretions to the proximal pathways. The consequence of poor drainage of secretions is triggered by retention of secretions, atelectasis, and ventilator-associated pneumonia (VAP).
Humidification and heating of the air with devices added to the imv together with respiratory physiotherapy aim to prevent and / or treat respiratory complications. Respiratory physiotherapy in the intubated patient facilitates the mobilization of retained and impacted secretions in the bronchial tree, helping to decrease resistance, improve lung compliance, and decrease respiratory muscle work.
Respiratory physiotherapy consists of a variety of devices and manual techniques to improve secretion drainage, ventilatory mechanics, and gas exchange.
The lack of scientific evidence on the effect and efficacy of respiratory physiotherapy in the patient with imv makes it difficult for the physiotherapist to perform his task with certainty of the impact of the intervention on lung physiology. Published clinical guidelines recommend the application of respiratory physiotherapy techniques to critically ill patients, but the need to demonstrate their effects with well-designed, quality studies and conclusive results is emphasized.
The aim of this study is to analyze the effect of the technique developed by the Belgian physiotherapist Jean Chevaillier, called assisted autogen drainage (AAD), on the intubated patient.
AAD is defined as a secretion drainage technique where the goal is to create a sufficiently sustained, homogeneous and synchronous expiratory flow, increasing speed, and seeking an erosion effect on secretions at different levels of the bronchial tree.
In the review of the literature on respiratory physiotherapy in the area of critics and in patients with IMV, articles have been found with different techniques such as hyperinsufflation, techniques for increasing the expiratory flow such as squeezing or rib cage. compression ". These demonstrate the safety of the techniques but there is controversy over the effect of maneuvers on the drainage of secretions and ventilatory mechanics. The point of discussion in the discussion of the authors of the meta-analyzes and studies is the need for new studies evaluating the effectiveness of respiratory physiotherapy in lung mechanics.
Hypothesis Respiratory physiotherapy applied through assisted autogenous drainage increases respiratory flow in the airways and therefore may modify respiratory mechanics and promote drainage in ventilated patients.
- Conditions
- Respiratory Physiotherapy
- Being tested
- respiratory physiotherapy (AAD)
- Keywords
- respiratory physiotherapy, invasive ventilation, critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory physiotherapy (AAD)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
The following physiological variables will be obtained through the BC Link software, re using the services of the I3PT signal laboratory.
Measured: 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)
The following physiological variables will be obtained through the BC Link software, re using the services of the I3PT signal laboratory.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Mar 2022
- Primary completion1 Nov 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Respiratory PhysiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, julia estela, Parc Taulí Hospital Universitari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551636
- Sponsor's protocol ID
- 2019685
- Status last verified
- Aug 2024
- First submitted
- 20 May 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8275739Pneumatikos 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.
PubMed 19212256Pattanshetty 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.
PubMed 23364504Spapen 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.
PubMed 28203436Branson RD. Secretion management in the mechanically ventilated patient. Respir Care. 2007 Oct;52(10):1328-42; discussion 1342-7.
PubMed 17894902Volsko TA. Airway clearance therapy: finding the evidence. Respir Care. 2013 Oct;58(10):1669-78. doi: 10.4187/respcare.02590.
PubMed 24064626Ambrosino 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.
PubMed 21782380Calvo-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.
PubMed 23949645Guimaraes 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.
PubMed 24106324Borges 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.
PubMed 28444078Gosselink 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.
PubMed 18283429
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Expiratoriy Flow of Assisted Autogen Drainage in a Critical Patient Wtih Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06551636
- Acronym / sponsor ID
- 2019685
- Conditions
- Respiratory Physiotherapy
- Keywords
- respiratory physiotherapy, invasive ventilation, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ventilated air blown into the bronchial shaft through the orotracheal tube (OT) causes ciliary dyskinesia by decreasing the rate of progression of secretions to the proximal pathways. The consequence of poor drainage of secretions is triggered by retention of secretions, atelectasis, and ventilator-associated pneumonia (VAP).
Humidification and heating of the air with devices added to the imv together with respiratory physiotherapy aim to prevent and / or treat respiratory complications. Respiratory physiotherapy in the intubated patient facilitates the mobilization of retained and impacted secretions in the bronchial tree, helping to decrease resistance, improve lung compliance, and decrease respiratory muscle work.
Respiratory physiotherapy consists of a variety of devices and manual techniques to improve secretion drainage, ventilatory mechanics, and gas exchange.
The lack of scientific evidence on the effect and efficacy of respiratory physiotherapy in the patient with imv makes it difficult for the physiotherapist to perform his task with certainty of the impact of the intervention on lung physiology. Published clinical guidelines recommend the application of respiratory physiotherapy techniques to critically ill patients, but the need to demonstrate their effects with well-designed, quality studies and conclusive results is emphasized.
The aim of this study is to analyze the effect of the technique developed by the Belgian physiotherapist Jean Chevaillier, called assisted autogen drainage (AAD), on the intubated patient.
AAD is defined as a secretion drainage technique where the goal is to create a sufficiently sustained, homogeneous and synchronous expiratory flow, increasing speed, and seeking an erosion effect on secretions at different levels of the bronchial tree.
In the review of the literature on respiratory physiotherapy in the area of critics and in patients with IMV, articles have been found with different techniques such as hyperinsufflation, techniques for increasing the expiratory flow such as squeezing or rib cage. compression ". These demonstrate the safety of the techniques but there is controversy over the effect of maneuvers on the drainage of secretions and ventilatory mechanics. The point of discussion in the discussion of the authors of the meta-analyzes and studies is the need for new studies evaluating the effectiveness of respiratory physiotherapy in lung mechanics.
Hypothesis Respiratory physiotherapy applied through assisted autogenous drainage increases respiratory flow in the airways and therefore may modify respiratory mechanics and promote drainage in ventilated patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory physiotherapy (AAD)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. | Other | – |
Primary outcome
To measure the expiratory flow in the intubated patient
Time frame: 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.
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)
2 secondary outcomes
To observe if the application of the AAD maneuver improves, produces changes in the respiratory mechanics; Compliance; Cst= Vt/Pplat-PEEP (ml/cmH2O)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 8275739Konrad 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.
- Background: PubMed 19212256Pneumatikos 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.
- Background: PubMed 23364504Pattanshetty 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.
- Background: PubMed 28203436Spapen 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.
- Background: PubMed 17894902Branson RD. Secretion management in the mechanically ventilated patient. Respir Care. 2007 Oct;52(10):1328-42; discussion 1342-7.
- Background: PubMed 24064626Volsko TA. Airway clearance therapy: finding the evidence. Respir Care. 2013 Oct;58(10):1669-78. doi: 10.4187/respcare.02590.
- Background: PubMed 21782380Ambrosino 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.
- Background: PubMed 23949645Calvo-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.
- Background: PubMed 24106324Guimaraes 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.
- Background: PubMed 28444078Borges 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.
- Background: PubMed 18283429Gosselink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Physiotherapy, run by Parc Taulí Hospital Universitari at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the expiratory flow in the intubated patient (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551636, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.