NCT06182553

Brief Summary

Mechanical ventilation (MV) is crucial in managing respiratory insufficiency. However, prolonged use can cause complications. Various strategies have been explored to optimize patient outcomes. Patients receiving IMV face multiple challenges in clearing lung secretions, such as inadequate humidification, high oxygen fractions, use of sedatives/analgesics, basal lung disease, and mechanical interference with secretion elimination near the trachea. Airway suctioning may not be sufficient in clearing the airway of mechanically ventilated patients, especially if they are paralyzed or lack a preserved cough reflex. This can lead to secretion retention, which may cause hypoxemia, atelectasis, ventilator-associated pneumonia, and delay weaning from MV. Bronchial hygiene is believed to improve respiratory system compliance by increasing Cdyn and Cst. Airway clearance techniques are commonly used in the treatment of patients with IMV to improve their pulmonary function through bronchial clearance, expansion of collapsed lung areas, and balancing of the ventilation/perfusion ratio. Physiotherapy methods including postural drainage, manual rib-cage compression (MRC), manual hyperinflation, positive end-expiratory pressure-zero end-expiratory pressure (PEEP-ZEEP) maneuver, and tracheal suctioning can alleviate atelectasis and improve bronchial hygiene. Two effective techniques for improving lung function and gas exchange are Expiratory Rib Cage Compression (ERCC) and the PEEP-ZEEP maneuver. ERCC applies external pressure during expiration, and PEEP-ZEEP temporarily reduces Positive End-Expiratory Pressure (PEEP) to 0 cmH2O, followed by a rapid return to the original PEEP level during expiration. Both techniques help to mobilize and remove airway secretions, ultimately improving lung function and gas exchange.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

November 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 26, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • oxygenation

    partial pressure of oxygen tension (PaO2). (mmHg) Arterial oxygen saturation (SaO2). (100%) PaO2/FiO2 ratio, and oxygenation index (OI). (mmHg)

    (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes

  • ventilation

    The partial pressure of carbon dioxide (PaCO2). (mmHg) Tidal volume (Vt). (ml) Positive end-expiratory pressure (PEEP). (CmH2O) Peak inspiratory pressure (PIP). (CmH2O) Minute ventilation (Mv). (L/m) Inspiratory: Expiratory Ratio (I: E ratio). Friction of inspired Oxygen (FIO2). (100%) Pressure Support (PS). (CmH2O) Plateau Pressure (Ppt). (CmH2O) Oxygen flow rate. (L/m) Static compliance (Cst) and dynamic compliance (Cdyn). (L/CmH2O) Respiratory system resistance (Rsr). (CmH2O/L /Sec) Rapid shallow breathing index (RSBI). (Breath /m/L)

    (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes

  • airway-secretion removal

    1. Oxygenic parameters for airway clearance, such as SpO2 (100%) and end tidal carbon dioxide (ETCO2) (mmHg). 2. Sputum parameters that include volume (ml), colour, consistency of respiratory secretions cleared from the airways, and frequency of sputum suctioning. 3. Lung function parameters such as peak inspiratory flow (PIF) (L/m), peak expiratory flow (PEF) (L/m): PIF ratio, peak airway pressure-plateau pressure gradient during constant flow ventilation (CmH2O), respiratory rate (RR) (b/m), maximum airway pressure (CmH2O), and vital capacity (L). 4. Ventilator graphs, especially flow-volume loops. 5. Lung sound auscultation (presence or absence of chest crepitations).

    (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes

Secondary Outcomes (2)

  • duration of mechanical ventilation (days)

    5 days

  • length of ICU stay (days)

    from day 1 till discharge

Study Arms (4)

Group (1) : ERCC Group

EXPERIMENTAL

\- The researcher will implement the ERCC technique for 10 minutes as follows: the researcher will use both hands bilaterally to gradually squeeze the rib cage (on the anterolateral region of the chest at the level of the last six ribs) in conjunction with chest-wall vibration during the expiratory phase of the ventilatory cycle. From the end of inspiration to the end of expiration, an attempt will be made to compress the rib cage over the region of the lungs that is most affected and the force will be applied every 2 breaths only during the expiration, synchronizing the maneuver rate with the breathing frequency of the subject. At the end of each expiratory phase, rib-cage compression is interrupted to permit free manual hyperinflation-induced inspiration. The ERCC technique will be implemented twice per day.

Other: Expiratory Rib Cage Compression

Group (2) : PEEP-ZEEP Group

EXPERIMENTAL

* The researcher in the presence of the attending physician will apply the PEEP-ZEEP maneuver in the following manner: During the inspiration phase of the ventilatory cycle, it is proposed to increase PEEP to 15 cmH2O, while maintaining a PIP of 40 cmH2O. Following the completion of five ventilatory cycles, PEEP will be abruptly decreased to 0 cmH2O during the expiration phase, referred to as ZEEP. Subsequently, during the subsequent inspiration phase, PEEP will be restored to the previously established levels. The maneuver will be repeated for a duration of 10 minutes, with a gap of two ventilatory cycles between every repetition.The PEEP-ZEEP maneuver will be implemented twice per day. At the end of the PEEP-ZEEP maneuver, the patient will receive tracheal suction as mentioned before. * The patients will be monitored continuously, and the maneuver will be interrupted if the patients become hemodynamically unstable or develop psychomotor agitation.

Other: PEEP-ZEEP Maneuver

Group (3) : ERCC + PEEP-ZEEP Group

EXPERIMENTAL

The ERCC technique will be applied as mentioned above, followed by PEEP-ZEEP maneuvers according to the standard steps mentioned before. Also, the patients will be monitored continuously, and the maneuver will be interrupted if the patients become hemodynamically unstable or develop psychomotor agitation.

Other: ERCC + PEEP-ZEEP maneuver

Group (4) : control Group

NO INTERVENTION

* The researcher will observe the conventional nursing care provided by CCNs in the study settings which may affect oxygenation, ventilation, and airway clearance for 30 minutes twice daily for five consecutive days. These conventional nursing practices may include enteral feeding, changing patients' positions, routine suctioning, and other traditional physiotherapies such as chest percussion and vibration. * Part II of tool one will be used to assess physiological parameters, and tool two will be used to assess oxygenation, ventilation parameters, and airway clearance indicators for patients in the control group twice per day from the 1st day to the 5th day of the study pre and post-conventional nursing care.

Interventions

Expiratory rib cage compression (ERCC) In this study, ERCC is a technique consisting of bilateral manual compression of the lower rib cage (anterolateral region of the chest at the level of the six last ribs) gradually during the expiratory phase of the ventilatory cycle and release from the compression at the end of the expiration.

Group (1) : ERCC Group

PEEP-ZEEP maneuver In this study, PEEP-ZEEP maneuver refers to PEEP which stands for positive end-expiratory pressure, and ZEEP which stands for zero end-expiratory pressure. In this maneuver PEEP will be incremented to 15 cmH2O throughout five consecutive respiratory cycles, then immediately after the inspiratory phase of the fifth cycle has been ended ZEEP should be done by abruptly reducing PEEP value to 0 cmH2O. The PEEP-ZEEP maneuver should be performed in two sets, consisting of a total of 10 consecutive breathing cycles. Subsequently, the patient is ventilated according to his/her baseline ventilator parameters.

Group (2) : PEEP-ZEEP Group

\- The ERCC technique will be applied as mentioned above, then followed by PEEP-ZEEP maneuvers according to the standard steps mentioned before.

Group (3) : ERCC + PEEP-ZEEP Group

Eligibility Criteria

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

You may qualify if:

  • Patients who are aged ≥18 years.
  • Patients who have tracheal intubation and are likely to require MV for ≥72 hours.
  • Patients who are hemodynamically stable: Heart rate (HR): ≥ 60 b or ≤100 b/min, mean arterial pressure (MAP) ≥ 90 mmHg, central venous pressure ≥ 3 or ≤ 8 cmH2O.

You may not qualify if:

  • Patients with pneumothorax, rib fracture, and subcutaneous emphysema.
  • Patients with traumatic brain injuries and spinal cord injuries.
  • Patients with ARDS who require high PEEP levels (\>10 cmH2O).
  • Patients admitted with pneumonia.
  • Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

  • 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.

  • 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.

  • Zhang J, Wang X, Xie J, Shen L, Mo G, Xie L. Effects of THE PEEP-ZEEP Maneuver in Adults Receiving Mechanical Ventilation: A Systematic Review with Meta-Analysis. Heart Lung. 2024 Jan-Feb;63:159-166. doi: 10.1016/j.hrtlng.2023.10.010. Epub 2023 Nov 2.

  • Amaral BLR, de Figueiredo AB, Lorena DM, Oliveira ACO, Carvalho NC, Volpe MS. Effects of ventilation mode and manual chest compression on flow bias during the positive end- and zero end-expiratory pressure manoeuvre in mechanically ventilated patients: a randomised crossover trial. Physiotherapy. 2020 Mar;106:145-153. doi: 10.1016/j.physio.2018.12.007. Epub 2019 Feb 3.

  • de Oliveira TF, Peringer VS, Forgiarini Junior LA, Eibel B. PEEP-ZEEP Compared with Bag Squeezing and Chest Compression in Mechanically Ventilated Cardiac Patients: Randomized Crossover Clinical Trial. Int J Environ Res Public Health. 2023 Feb 5;20(4):2824. doi: 10.3390/ijerph20042824.

  • Herbst-Rodrigues MV, Carvalho VO, Auler JO Jr, Feltrim MI. PEEP-ZEEP technique: cardiorespiratory repercussions in mechanically ventilated patients submitted to a coronary artery bypass graft surgery. J Cardiothorac Surg. 2011 Sep 13;6:108. doi: 10.1186/1749-8090-6-108.

  • 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.

  • Volpe MS, Guimaraes FS, Morais CC. Airway Clearance Techniques for Mechanically Ventilated Patients: Insights for Optimization. Respir Care. 2020 Aug;65(8):1174-1188. doi: 10.4187/respcare.07904.

  • Oliveira ACO, Lorena DM, Gomes LC, Amaral BLR, Volpe MS. Effects of manual chest compression on expiratory flow bias during the positive end-expiratory pressure-zero end-expiratory pressure maneuver in patients on mechanical ventilation. J Bras Pneumol. 2019 Mar 11;45(3):e20180058. doi: 10.1590/1806-3713/e20180058.

  • Dyhr T, Laursen N, Larsson A. Effects of lung recruitment maneuver and positive end-expiratory pressure on lung volume, respiratory mechanics and alveolar gas mixing in patients ventilated after cardiac surgery. Acta Anaesthesiol Scand. 2002 Jul;46(6):717-25. doi: 10.1034/j.1399-6576.2002.460615.x.

  • 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.

  • Unoki T, Mizutani T, Toyooka H. Effects of expiratory rib cage compression and/or prone position on oxygenation and ventilation in mechanically ventilated rabbits with induced atelectasis. Respir Care. 2003 Aug;48(8):754-62.

  • Bousarri MP, Shirvani Y, Agha-Hassan-Kashani S, Nasab NM. The effect of expiratory rib cage compression before endotracheal suctioning on the vital signs in patients under mechanical ventilation. Iran J Nurs Midwifery Res. 2014 May;19(3):285-9.

  • Jalil Y, Damiani LF, Basoalto R, Bachmman MC, Bruhn A. A deep look into the rib cage compression technique in mechanically ventilated patients: a narrative review. Rev Bras Ter Intensiva. 2022 Jan-Mar;34(1):176-184. doi: 10.5935/0103-507X.20220012-pt.

  • Van der Touw T, Mudaliar Y, Nayyar V. Cardiorespiratory effects of manually compressing the rib cage during tidal expiration in mechanically ventilated patients recovering from acute severe asthma. Crit Care Med. 1998 Aug;26(8):1361-7. doi: 10.1097/00003246-199808000-00021.

  • Hosoe T, Tanaka T, Hamasaki H, Nonoyama K. Effect of positioning and expiratory rib-cage compression on atelectasis in a patient who required prolonged mechanical ventilation: a case report. J Med Case Rep. 2022 Jun 23;16(1):265. doi: 10.1186/s13256-022-03389-5.

  • Kohan M, Mohammad-Taheri N. Expiratory rib cage compression, endotracheal suctioning, and vital signs. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):343. doi: 10.4103/1735-9066.180383. No abstract available.

  • Berti JS, Tonon E, Ronchi CF, Berti HW, Stefano LM, Gut AL, Padovani CR, Ferreira AL. Manual hyperinflation combined with expiratory rib cage compression for reduction of length of ICU stay in critically ill patients on mechanical ventilation. J Bras Pneumol. 2012 Jul-Aug;38(4):477-86. doi: 10.1590/s1806-37132012000400010. English, Portuguese.

  • Mase K, Yamamoto K, Murakami S, Kihara K, Matsushita K, Nozoe M, Takashima S. Changes in ventilation mechanics during expiratory rib cage compression in healthy males. J Phys Ther Sci. 2018 Jun;30(6):820-824. doi: 10.1589/jpts.30.820. Epub 2018 Jun 12.

  • Ntoumenopoulos G. Expiratory rib-cage compression, airway suctioning, and atelectasis. Respir Care. 2005 Mar;50(3):387; author reply 387-8. No abstract available.

  • Ouchi A, Sakuramoto H, Unoki T, Yoshino Y, Hosino H, Koyama Y, Enomoto Y, Shimojo N, Mizutani T, Inoue Y. Effects of Manual Rib Cage Compressions on Mucus Clearance in Mechanically Ventilated Pigs. Respir Care. 2020 Aug;65(8):1135-1140. doi: 10.4187/respcare.07249. Epub 2020 Feb 11.

  • Morino A, Shida M, Tanaka M, Sato K, Seko T, Ito S, Ogawa S, Takahashi N. Comparison of changes in tidal volume associated with expiratory rib cage compression and expiratory abdominal compression in patients on prolonged mechanical ventilation. J Phys Ther Sci. 2015 Jul;27(7):2253-6. doi: 10.1589/jpts.27.2253. Epub 2015 Jul 22.

  • D'Angelo E, Miserocchi G, Agostoni E. Effect of rib cage or abdomen compression at iso-lung volume on breathing pattern. Respir Physiol. 1976 Nov;28(2):161-77. doi: 10.1016/0034-5687(76)90036-0.

Study Officials

  • Sahar Younes Othman, ASS-PROF

    Damanhour University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Adel Hasanain Sherif, Demonstrator

CONTACT

Alaa Mostafa Mohamed, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with four parallel groups will be used in the current study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 27, 2023

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12