Mechanically Ventilated PatientsNCT06182553
Effect of ERCC and/or PEEP-ZEEP Maneuver on Oxygenation, Ventilation, and Airway Secretions Removal in MV Patients
A study testing Expiratory Rib Cage Compression, PEEP-ZEEP Maneuver and ERCC + PEEP-ZEEP maneuver in people with Mechanically Ventilated Patients, run by Damanhour University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- Expiratory Rib Cage Compression, PEEP-ZEEP Maneuver and ERCC + PEEP-ZEEP maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Aug 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Expiratory Rib Cage Compression and/or PEEP-ZEEP Maneuver on Oxygenation, Ventilation, and Airway Secretions Removal in Mechanically Ventilated Patients
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.
Read more
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.
Read the detailed description
Expiratory rib cage compression is a form of chest physiotherapy that involves squeezing the chest with the hands during expiration and releasing it at the end of expiration to aid in the mobilization of lung secretions, facilitate comfortable inspiration, and promote alveolar ventilation. The concept of manual chest compression was first explored in the 1950s, when Opie et al. proposed that local chest compression produces a "toothpaste" effect, which helps to expel the retained material through the bronchus. This phenomenon piqued the interest of other researchers, leading to a better understanding of the functioning of the mucous layer and the development of therapeutic strategies to improve it.
This technique increases forced expiratory volume by 30% and leads to the resting of the expiratory muscles. Most of all, the technique is quite safe, as it has been employed in some patients for more than 3 years with no complications. Therefore, this technique can be used before the patients' endotracheal suctioning interventions, and it is widely used with mechanically ventilated patients to prevent and/or to treat atelectasis. In addition, removing secretion is essential because accumulated secretions intervene in gas exchange and may delay recovery; coughing can be initiated voluntarily or by reflex.
The positive end-expiratory pressure-zero end-expiratory pressure maneuver considers that by raising PEEP to 15 cmH2O during five cycles, followed by an abrupt reduction of PEEP to 0 cmH2O, gas redistribution occurs through collateral ventilation. Subsequently, small airways are opened, and the adhered mucus is displaced. With the reduction of PEEP, the expiratory flow pattern is modified, causing the secretions located in smaller airways to be transported to the central airways.
While many studies have looked at the effects of rib cage compression (RCC) or the PEEP-ZEEP maneuver individually, there is a need for comparative studies that directly compare these two techniques. Understanding the different effects of these interventions on oxygenation, ventilation, and airway-secretion removal can help critical care nurses (CCNs) choose the most effective strategy for mechanically ventilated patients. Therefore, the purpose of this study is to compare the effects of RCC and the PEEP-ZEEP maneuver on oxygenation, ventilation, and airway-secretion removal in mechanically ventilated patients. By evaluating these outcomes, we can gain insights into the potential benefits and limitations of each technique, ultimately contributing to the optimization of respiratory support strategies in critically ill patients.
The findings of this study can have important implications for CCN clinical practice as they can inform CCNs about the efficacy and safety of RCC and the PEEP-ZEEP maneuver. Improving oxygenation, ventilation, and airway-secretion removal in mechanically ventilated patients can lead to enhanced patient outcomes, reduced complications, and potentially shorter durations of mechanical ventilation and intensive care unit stays.
- Conditions
- Mechanically Ventilated Patients
- Being tested
- Expiratory Rib Cage Compression, PEEP-ZEEP Maneuver, ERCC + PEEP-ZEEP maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Rib Cage CompressionOther
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.
PEEP-ZEEP ManeuverOther
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.
ERCC + PEEP-ZEEP maneuverOther
- The ERCC technique will be applied as mentioned above, then followed by PEEP-ZEEP maneuvers according to the standard steps mentioned before.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation
partial pressure of oxygen tension (PaO2). (mmHg) Arterial oxygen saturation (SaO2). (100%) PaO2/FiO2 ratio, and oxygenation index (OI). (mmHg)
Measured: (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)
Measured: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes
airway-secretion removal
- Oxygenic parameters for airway clearance, such as SpO2 (100%) and end tidal carbon dioxide (ETCO2) (mmHg).
- Sputum parameters that include volume (ml), colour, consistency of respiratory secretions cleared from the airways, and frequency of sputum suctioning.
- 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).
- Ventilator graphs, especially flow-volume loops.
- Lung sound auscultation (presence or absence of chest crepitations).
Measured: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes
Secondary outcomes (2)
duration of mechanical ventilation (days)
effect of ERCC and/or PEEP-ZEEP maneuvers on duration of mechanical ventilation (days)
Measured: 5 days
length of ICU stay (days)
effect of ERCC and/or PEEP-ZEEP maneuvers on length of ICU stay (days).
Measured: from day 1 till discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Mechanically Ventilated PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with four parallel groups will be used in the current study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahar Younes Othman, ASS-PROF, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182553
- Sponsor's protocol ID
- MV Patients
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16253149Borges 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 28444078Zhang 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.
PubMed 37922664Amaral 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.
PubMed 30979507de 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.
PubMed 36833521Herbst-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.
PubMed 21914178Santos 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.
PubMed 25303345Volpe 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.
PubMed 32712584Oliveira 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.
PubMed 30864618Dyhr 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.
PubMed 12059898Guimaraes 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 24106324Unoki 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.
PubMed 12890295Bousarri 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.
PubMed 24949068Jalil 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.
PubMed 35766667Van 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.
PubMed 9710095
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Rib Cage Compression and/or PEEP-ZEEP Maneuver on Oxygenation, Ventilation, and Airway Secretions Removal in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06182553
- Acronym / sponsor ID
- MV Patients
- Conditions
- Mechanically Ventilated Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Dec 2023 (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.
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.
Detailed description
Expiratory rib cage compression is a form of chest physiotherapy that involves squeezing the chest with the hands during expiration and releasing it at the end of expiration to aid in the mobilization of lung secretions, facilitate comfortable inspiration, and promote alveolar ventilation. The concept of manual chest compression was first explored in the 1950s, when Opie et al. proposed that local chest compression produces a "toothpaste" effect, which helps to expel the retained material through the bronchus. This phenomenon piqued the interest of other researchers, leading to a better understanding of the functioning of the mucous layer and the development of therapeutic strategies to improve it.
This technique increases forced expiratory volume by 30% and leads to the resting of the expiratory muscles. Most of all, the technique is quite safe, as it has been employed in some patients for more than 3 years with no complications. Therefore, this technique can be used before the patients' endotracheal suctioning interventions, and it is widely used with mechanically ventilated patients to prevent and/or to treat atelectasis. In addition, removing secretion is essential because accumulated secretions intervene in gas exchange and may delay recovery; coughing can be initiated voluntarily or by reflex.
The positive end-expiratory pressure-zero end-expiratory pressure maneuver considers that by raising PEEP to 15 cmH2O during five cycles, followed by an abrupt reduction of PEEP to 0 cmH2O, gas redistribution occurs through collateral ventilation. Subsequently, small airways are opened, and the adhered mucus is displaced. With the reduction of PEEP, the expiratory flow pattern is modified, causing the secretions located in smaller airways to be transported to the central airways.
While many studies have looked at the effects of rib cage compression (RCC) or the PEEP-ZEEP maneuver individually, there is a need for comparative studies that directly compare these two techniques. Understanding the different effects of these interventions on oxygenation, ventilation, and airway-secretion removal can help critical care nurses (CCNs) choose the most effective strategy for mechanically ventilated patients. Therefore, the purpose of this study is to compare the effects of RCC and the PEEP-ZEEP maneuver on oxygenation, ventilation, and airway-secretion removal in mechanically ventilated patients. By evaluating these outcomes, we can gain insights into the potential benefits and limitations of each technique, ultimately contributing to the optimization of respiratory support strategies in critically ill patients.
The findings of this study can have important implications for CCN clinical practice as they can inform CCNs about the efficacy and safety of RCC and the PEEP-ZEEP maneuver. Improving oxygenation, ventilation, and airway-secretion removal in mechanically ventilated patients can lead to enhanced patient outcomes, reduced complications, and potentially shorter durations of mechanical ventilation and intensive care unit stays.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized controlled trial with four parallel groups will be used in the current study.
| Arm | Type | Receives |
|---|---|---|
| Group (1) : ERCC Group | Experimental | Other: Expiratory Rib Cage Compression- 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. |
| Group (2) : PEEP-ZEEP Group | Experimental | Other: PEEP-ZEEP Maneuver* 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. |
| Group (3) : ERCC + PEEP-ZEEP Group | Experimental | Other: ERCC + PEEP-ZEEP maneuverThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Expiratory Rib Cage CompressionExpiratory 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. | Other | Group (1) : ERCC Group |
| PEEP-ZEEP ManeuverPEEP-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. | Other | Group (2) : PEEP-ZEEP Group |
| ERCC + PEEP-ZEEP maneuver- The ERCC technique will be applied as mentioned above, then followed by PEEP-ZEEP maneuvers according to the standard steps mentioned before. | Other | Group (3) : ERCC + PEEP-ZEEP Group |
Primary outcome
oxygenation
Time frame: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes
partial pressure of oxygen tension (PaO2). (mmHg) Arterial oxygen saturation (SaO2). (100%) PaO2/FiO2 ratio, and oxygenation index (OI). (mmHg)
ventilation
Time frame: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes
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)
airway-secretion removal
Time frame: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes
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).
2 secondary outcomes
duration of mechanical ventilation (days)
Time frame: 5 days
length of ICU stay (days)
Time frame: from day 1 till discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Results publication: PubMed 16253149Unoki 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.
- Results publication: 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.
- Results publication: PubMed 37922664Zhang 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.
- Results publication: PubMed 30979507Amaral 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.
- Results publication: PubMed 36833521de 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.
- Results publication: PubMed 21914178Herbst-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.
- Results publication: PubMed 25303345Santos 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.
- Results publication: PubMed 32712584Volpe 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.
- Results publication: PubMed 30864618Oliveira 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.
- Results publication: PubMed 12059898Dyhr 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.
- Results publication: 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.
- Results publication: PubMed 12890295Unoki 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.
Related trials for Mechanically Ventilated Patients
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
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.
Sahar Younes Othman, ASS-PROF study director
Damanhour University
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Rib Cage Compression, PEEP-ZEEP Maneuver and ERCC + PEEP-ZEEP maneuver in people with Mechanically Ventilated Patients, run by Damanhour University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Adel Hasanain Sherif, Demonstrator (01064660098, mahmoud.sherif@nur.dmu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation (time frame: (T0) pre-intervention, (T1) immediately after the intervention, and (T3) up to 30 minutes). The study lists 3 primary outcomes in all. 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 NCT06182553, which also lists 23 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 27 Dec 2023.