Effect of ERCC and/or PEEP-ZEEP Maneuver on Oxygenation, Ventilation, and Airway Secretions Removal in MV Patients

NCT ID: NCT06182553

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-08-31

Brief Summary

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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

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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

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Mechanically Ventilated Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial with four parallel groups will be used in the current study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group (1) : ERCC Group

\- 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 Type EXPERIMENTAL

Expiratory Rib Cage Compression

Intervention Type OTHER

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 (2) : PEEP-ZEEP Group

* 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 Type EXPERIMENTAL

PEEP-ZEEP Maneuver

Intervention Type OTHER

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 (3) : ERCC + PEEP-ZEEP Group

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.

Group Type EXPERIMENTAL

ERCC + PEEP-ZEEP maneuver

Intervention Type OTHER

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

Group (4) : control Group

* 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Expiratory Rib Cage Compression

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.

Intervention Type OTHER

PEEP-ZEEP Maneuver

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sahar Younes Othman, ASS-PROF

Role: STUDY_DIRECTOR

Damanhour University

Central Contacts

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Mahmoud Adel Hasanain Sherif, Demonstrator

Role: CONTACT

Phone: 01064660098

Email: [email protected]

Alaa Mostafa Mohamed, Lecturer

Role: CONTACT

Phone: 01097210526

Email: [email protected]

References

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Other Identifiers

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MV Patients

Identifier Type: -

Identifier Source: org_study_id