Air Stacking Technique For Pulmonary Reexpansion

NCT05702411 | Unknown

• 1 other identifier: 50845721.0.0000.5530
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-over randomized clinical trial carried out at the Intensive Care Unit. Patients who are on mechanical ventilation for more than 24 hours will be included in the study. The following techniques will be applied: aspiration in a closed system with an expiratory pause of 10 seconds associated to hyperinflation maneuver with a mechanical ventilator with the Air Stacking technique and aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

Conditions

Critical Care

Keywords

pulmonary reexpansion; air stacking; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Tidal Volume (VT) (ml)

  The tidal volume will be visualized directly at mechanical ventilation monitor. Variations in tidal volume will be considered before and after the interventions.

  At 30-minute after the application of the studied technique.

Secondary Outcomes (13)

• Weight of secretion aspirated (grams)

  Immediately after the application of one of the protocols.

• Peripheral arterial oxygen saturation (SpO2) (%)

  1, 10 and 30-minute after the application of the studied technique.

• Peak inspiratory pressure (PIP) (cm H2O)

  1, 10 and 30-minute after the application of the studied technique.

• End expiratory pressure (PEEP) (cmH2O)

  1, 10 and 30-minute after the application of the studied technique.

• Air trapping (AUTO-PEEP) (cmH2O)

  1, 10 and 30-minute after the application of the studied technique.

Study Arms (2)

Protocol 1

EXPERIMENTAL

Closed system aspiration with an expiratory pause of 10 seconds followed by hyper insufflation maneuver with the Air Stacking technique.

Other: Air Stacking Technique

Protocol 2

EXPERIMENTAL

Closed system aspiration with an expiratory pause of 10 seconds.

Other: No Air Stacking Technique

Interventions

Air Stacking Technique OTHER

Air Stacking lung reexpansion technique after aspiration with expiratory pause in a closed system.

Protocol 1

No Air Stacking Technique OTHER

Aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

Protocol 2

Eligibility Criteria

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

You may qualify if:

• patients 18 years or older
• patients on mechanical ventilation for more than 48 hours
• patients on volume or pressure controlled ventilatory mode
• patients hemodynamically stable (equal mean blood pressure or more than 60 mmHg, and dose of Norepinephrine less than 1μg / Kg / minute)
• patients whose legal representatives authorize participation in the study.

You may not qualify if:

• undrained pneumothorax and hemothorax, and emphysema subcutaneous
• fracture of ribs
• ventilatory parameters with peak pressure greater than 40 cm/H2O

Sponsors & Collaborators

• Hospital Nossa Senhora da Conceicao: lead

Study Sites (1)

Hospital Cristo Redentor

Porto Alegre, Rio Grande do Sul, 91040000, Brazil

RECRUITING

Related Publications (55)

• Slutsky AS. History of Mechanical Ventilation. From Vesalius to Ventilator-induced Lung Injury. Am J Respir Crit Care Med. 2015 May 15;191(10):1106-15. doi: 10.1164/rccm.201503-0421PP.

  PMID: 25844759 BACKGROUND

• Walter JM, Corbridge TC, Singer BD. Invasive Mechanical Ventilation. South Med J. 2018 Dec;111(12):746-753. doi: 10.14423/SMJ.0000000000000905.

  PMID: 30512128 BACKGROUND

• Pham T, Brochard LJ, Slutsky AS. Mechanical Ventilation: State of the Art. Mayo Clin Proc. 2017 Sep;92(9):1382-1400. doi: 10.1016/j.mayocp.2017.05.004.

  PMID: 28870355 BACKGROUND

• Van der Schans CP. Bronchial mucus transport. Respir Care. 2007 Sep;52(9):1150-6; discussion 1156-8.

  PMID: 17716383 BACKGROUND

• American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

  PMID: 15699079 BACKGROUND

• Niel-Weise BS, Snoeren RL, van den Broek PJ. Policies for endotracheal suctioning of patients receiving mechanical ventilation: a systematic review of randomized controlled trials. Infect Control Hosp Epidemiol. 2007 May;28(5):531-6. doi: 10.1086/513726. Epub 2007 Mar 22.

  PMID: 17464911 BACKGROUND

• Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. doi: 10.1093/ptj/76.6.609.

  PMID: 8650276 BACKGROUND

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

  PMID: 17894902 BACKGROUND

• American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

  PMID: 20507660 BACKGROUND

• Pagotto IM, Oliveira LR, Araujo FC, Carvalho NA, Chiavone P. Comparison between open and closed suction systems: a systematic review. Rev Bras Ter Intensiva. 2008 Dec;20(4):331-8. English, Portuguese.

  PMID: 25307236 BACKGROUND

• Lopes FM, Lopez MF. Impact of the open and closed tracheal suctioning system on the incidence of mechanical ventilation associated pneumonia: literature review. Rev Bras Ter Intensiva. 2009 Mar;21(1):80-8. English, Portuguese.

  PMID: 25303133 BACKGROUND

• de Fraga Gomes Martins L, da Silva Naue W, Skueresky AS, Bianchi T, Dias AS, Forgiarini LA. Effects of Combined Tracheal Suctioning and Expiratory Pause: A Crossover Randomized Clinical Trial. Indian J Crit Care Med. 2019 Oct;23(10):454-457. doi: 10.5005/jp-journals-10071-23263.

  PMID: 31749553 BACKGROUND

• Stiller K. Physiotherapy in intensive care: an updated systematic review. Chest. 2013 Sep;144(3):825-847. doi: 10.1378/chest.12-2930.

  PMID: 23722822 BACKGROUND

• Smith DJ, Gaffney EA, Blake JR. Modelling mucociliary clearance. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):178-88. doi: 10.1016/j.resp.2008.03.006. Epub 2008 Mar 20.

  PMID: 18439882 BACKGROUND

• Karamaoun C, Sobac B, Mauroy B, Van Muylem A, Haut B. New insights into the mechanisms controlling the bronchial mucus balance. PLoS One. 2018 Jun 22;13(6):e0199319. doi: 10.1371/journal.pone.0199319. eCollection 2018.

  PMID: 29933368 BACKGROUND

• Pieterse A, Hanekom SD. Criteria for enhancing mucus transport: a systematic scoping review. Multidiscip Respir Med. 2018 Jul 6;13:22. doi: 10.1186/s40248-018-0127-6. eCollection 2018.

  PMID: 29988934 BACKGROUND

• Konrad F, Schiener R, Marx T, Georgieff M. Ultrastructure and mucociliary transport of bronchial respiratory epithelium in intubated patients. Intensive Care Med. 1995 Jun;21(6):482-9. doi: 10.1007/BF01706201.

  PMID: 7560491 BACKGROUND

• Savian C, Paratz J, Davies A. Comparison of the effectiveness of manual and ventilator hyperinflation at different levels of positive end-expiratory pressure in artificially ventilated and intubated intensive care patients. Heart Lung. 2006 Sep-Oct;35(5):334-41. doi: 10.1016/j.hrtlng.2006.02.003.

  PMID: 16963365 BACKGROUND

• Coppadoro A, Bellani G, Foti G. Non-Pharmacological Interventions to Prevent Ventilator-Associated Pneumonia: A Literature Review. Respir Care. 2019 Dec;64(12):1586-1595. doi: 10.4187/respcare.07127. Epub 2019 Sep 24.

  PMID: 31551284 BACKGROUND

• AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA. Medidas de Prevenção de Infecção Relacionada à Assistência à Saúde.; 2017.

  BACKGROUND

• Franca EE, Ferrari F, Fernandes P, Cavalcanti R, Duarte A, Martinez BP, Aquim EE, Damasceno MC. Physical therapy in critically ill adult patients: recommendations from the Brazilian Association of Intensive Care Medicine Department of Physical Therapy. Rev Bras Ter Intensiva. 2012 Mar;24(1):6-22. English, Portuguese.

  PMID: 23917708 BACKGROUND

• Naue Wda S, da Silva AC, Guntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6. doi: 10.1016/S1836-9553(11)70003-0.

  PMID: 21402326 BACKGROUND

• van der Schans CP, Postma DS, Koeter GH, Rubin BK. Physiotherapy and bronchial mucus transport. Eur Respir J. 1999 Jun;13(6):1477-86. doi: 10.1183/09031936.99.13614879.

  PMID: 10445628 BACKGROUND

• Ardehali SH, Fatemi A, Rezaei SF, Forouzanfar MM, Zolghadr Z. The Effects of Open and Closed Suction Methods on Occurrence of Ventilator Associated Pneumonia; a Comparative Study. Arch Acad Emerg Med. 2020 Jan 11;8(1):e8. eCollection 2020.

  PMID: 32021989 BACKGROUND

• Letchford E, Bench S. Ventilator-associated pneumonia and suction: a review of the literature. Br J Nurs. 2018 Jan 11;27(1):13-18. doi: 10.12968/bjon.2018.27.1.13.

  PMID: 29323990 BACKGROUND

• Taggart JA, Dorinsky NL, Sheahan JS. Airway pressures during closed system suctioning. Heart Lung. 1988 Sep;17(5):536-42.

  PMID: 3417464 BACKGROUND

• Palazzo SG, Soni B. Pressure changes during tracheal suctioning--a laboratory study. Anaesthesia. 2013 Jun;68(6):576-84. doi: 10.1111/anae.12218.

  PMID: 23662749 BACKGROUND

• Santos FR, Schneider Junior LC, Forgiarini Junior LA, Veronezi J. Effects of manual rib-cage compression versus PEEP-ZEEP maneuver on respiratory system compliance and oxygenation in patients receiving mechanical ventilation. Rev Bras Ter Intensiva. 2009 Jun;21(2):155-61. English, Portuguese.

  PMID: 25303345 BACKGROUND

• 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: 28203436 BACKGROUND

• Rosa FK, Roese CA, Savi A, Dias AS, Monteiro MB. [Behavior of the lung mechanics after the application of protocol of chest physiotherapy and aspiration tracheal in patients with invasive mechanical ventilation]. Rev Bras Ter Intensiva. 2007 Jun;19(2):170-5. Portuguese.

  PMID: 25310775 BACKGROUND

• Jones A, Rowe BH. Bronchopulmonary hygiene physical therapy in bronchiectasis and chronic obstructive pulmonary disease: a systematic review. Heart Lung. 2000 Mar-Apr;29(2):125-35.

  PMID: 10739489 BACKGROUND

• Hodgson C, Denehy L, Ntoumenopoulos G, Santamaria J, Carroll S. An investigation of the early effects of manual lung hyperinflation in critically ill patients. Anaesth Intensive Care. 2000 Jun;28(3):255-61. doi: 10.1177/0310057X0002800302.

  PMID: 10853205 BACKGROUND

• Unoki T, Kawasaki Y, Mizutani T, Fujino Y, Yanagisawa Y, Ishimatsu S, Tamura F, Toyooka H. Effects of expiratory rib-cage compression on oxygenation, ventilation, and airway-secretion removal in patients receiving mechanical ventilation. Respir Care. 2005 Nov;50(11):1430-7.

  PMID: 16253149 BACKGROUND

• Avena Kde M, Duarte AC, Cravo SL, Sologuren MJ, Gastaldi AC. [Effects of manually assisted coughing on respiratory mechanics in patients requiring full ventilatory support]. J Bras Pneumol. 2008 Jun;34(6):380-6. doi: 10.1590/s1806-37132008000600008. Portuguese.

  PMID: 18622505 BACKGROUND

• Brito MF, Moreira GA, Pradella-Hallinan M, Tufik S. Air stacking and chest compression increase peak cough flow in patients with Duchenne muscular dystrophy. J Bras Pneumol. 2009 Oct;35(10):973-9. doi: 10.1590/s1806-37132009001000005. English, Portuguese.

  PMID: 19918629 BACKGROUND

• Iskandar K, Sunartini, Nugrahanto AP, Ilma N, Kalim AS, Adistyawan G, Siswanto, Naning R. Use of air stacking to improve pulmonary function in Indonesian Duchenne muscular dystrophy patients: bridging the standard of care gap in low middle income country setting. BMC Proc. 2019 Dec 16;13(Suppl 11):21. doi: 10.1186/s12919-019-0179-4. eCollection 2019.

  PMID: 31890014 BACKGROUND

• Pattanshetty RB, Gaude GS. Effect of multimodality chest physiotherapy in prevention of ventilator-associated pneumonia: A randomized clinical trial. Indian J Crit Care Med. 2010 Apr;14(2):70-6. doi: 10.4103/0972-5229.68218.

  PMID: 20859490 BACKGROUND

• 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: 23364504 BACKGROUND

• Pepe PE, Marini JJ. Occult positive end-expiratory pressure in mechanically ventilated patients with airflow obstruction: the auto-PEEP effect. Am Rev Respir Dis. 1982 Jul;126(1):166-70. doi: 10.1164/arrd.1982.126.1.166.

  PMID: 7046541 BACKGROUND

• Natalini G, Tuzzo D, Rosano A, Testa M, Grazioli M, Pennestri V, Amodeo G, Marsilia PF, Tinnirello A, Berruto F, Fiorillo M, Filippini M, Peratoner A, Minelli C, Bernardini A; VENTILAB Group. Assessment of Factors Related to Auto-PEEP. Respir Care. 2016 Feb;61(2):134-41. doi: 10.4187/respcare.04063. Epub 2015 Nov 24.

  PMID: 26604329 BACKGROUND

• Bugedo G, Retamal J, Bruhn A. Does the use of high PEEP levels prevent ventilator-induced lung injury? Rev Bras Ter Intensiva. 2017 Apr-Jun;29(2):231-237. doi: 10.5935/0103-507X.20170032.

  PMID: 28977263 BACKGROUND

• Volpe MS, Adams AB, Amato MB, Marini JJ. Ventilation patterns influence airway secretion movement. Respir Care. 2008 Oct;53(10):1287-94.

  PMID: 18811989 BACKGROUND

• Fink JB. Forced expiratory technique, directed cough, and autogenic drainage. Respir Care. 2007 Sep;52(9):1210-21; discussion 1221-3.

  PMID: 17716387 BACKGROUND

• Lasocki S, Lu Q, Sartorius A, Fouillat D, Remerand F, Rouby JJ. Open and closed-circuit endotracheal suctioning in acute lung injury: efficiency and effects on gas exchange. Anesthesiology. 2006 Jan;104(1):39-47. doi: 10.1097/00000542-200601000-00008.

  PMID: 16394688 BACKGROUND

• Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

  PMID: 28973363 BACKGROUND

• Das A, Cole O, Chikhani M, Wang W, Ali T, Haque M, Bates DG, Hardman JG. Evaluation of lung recruitment maneuvers in acute respiratory distress syndrome using computer simulation. Crit Care. 2015 Jan 12;19(1):8. doi: 10.1186/s13054-014-0723-6.

  PMID: 25578295 BACKGROUND

• Goligher EC, Hodgson CL, Adhikari NKJ, Meade MO, Wunsch H, Uleryk E, Gajic O, Amato MPB, Ferguson ND, Rubenfeld GD, Fan E. Lung Recruitment Maneuvers for Adult Patients with Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S304-S311. doi: 10.1513/AnnalsATS.201704-340OT.

  PMID: 29043837 BACKGROUND

• Hartland BL, Newell TJ, Damico N. Alveolar recruitment maneuvers under general anesthesia: a systematic review of the literature. Respir Care. 2015 Apr;60(4):609-20. doi: 10.4187/respcare.03488. Epub 2014 Nov 25.

  PMID: 25425708 BACKGROUND

• Corley A, Sharpe N, Caruana LR, Spooner AJ, Fraser JF. Lung volume changes during cleaning of closed endotracheal suction catheters: a randomized crossover study using electrical impedance tomography. Respir Care. 2014 Apr;59(4):497-503. doi: 10.4187/respcare.02601. Epub 2013 Sep 17.

  PMID: 24046466 BACKGROUND

• Almgren B, Wickerts CJ, Hogman M. Post-suction recruitment manoeuvre restores lung function in healthy, anaesthetized pigs. Anaesth Intensive Care. 2004 Jun;32(3):339-45. doi: 10.1177/0310057X0403200306.

  PMID: 15264727 BACKGROUND

• Chicayban LM. Acute effects of ventilator hyperinflation with increased inspiratory time on respiratory mechanics: randomized crossover clinical trial. Rev Bras Ter Intensiva. 2019 Oct 14;31(3):289-295. doi: 10.5935/0103-507X.20190052. eCollection 2019.

  PMID: 31618346 BACKGROUND

• Rothen HU, Neumann P, Berglund JE, Valtysson J, Magnusson A, Hedenstierna G. Dynamics of re-expansion of atelectasis during general anaesthesia. Br J Anaesth. 1999 Apr;82(4):551-6. doi: 10.1093/bja/82.4.551.

  PMID: 10472221 BACKGROUND

• Dohna-Schwake C, Ragette R, Teschler H, Voit T, Mellies U. IPPB-assisted coughing in neuromuscular disorders. Pediatr Pulmonol. 2006 Jun;41(6):551-7. doi: 10.1002/ppul.20406.

  PMID: 16617451 BACKGROUND

• Toussaint M, Pernet K, Steens M, Haan J, Sheers N. Cough Augmentation in Subjects With Duchenne Muscular Dystrophy: Comparison of Air Stacking via a Resuscitator Bag Versus Mechanical Ventilation. Respir Care. 2016 Jan;61(1):61-7. doi: 10.4187/respcare.04033. Epub 2015 Oct 6.

  PMID: 26443018 BACKGROUND

• Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24. doi: 10.1164/rccm.200203-195OC. Epub 2003 Feb 13.

  PMID: 12615633 BACKGROUND

Study Officials

• Fernanda M Kutchak, Master

  Grupo Hospitalar Conceição

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda M Kutchak, Master

CONTACT

+55 51 993196476; fernandakutchak@terra.com.br

Silvia RR Vieira, PhD

CONTACT

+555199686170; svieira@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: January 27, 2023
• Study Start: September 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)