Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06341244 |
| Other study ID # |
UNIFESP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2019 |
| Est. completion date |
December 15, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Universidade Cidade de Sao Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
After thoracic surgical intervention, patients often feel intense pain with respiratory
movements reduction making coughing less effective. The air stacking improves peak of
expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the
hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives:
To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF
and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic
surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure
(MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and
postoperatory.
Description:
Surgical intervention is a treatment option for many diseases of the thorax . After
thoracotomy, ventilatory patterns change, lung volumes and pulmonary capacities decrease due
to the reflex inhibition of the diaphragm muscle, and the sigh mechanism becomes impaired,
even if the procedure does not include pulmonary resection . These changes often lead to
postoperative pulmonary complications, which may increase length of stay in the hospital. The
role of physical therapy in minimizing these risks is critical, and several techniques are
available to improve both lung volume and capacity and to make coughing more effective. The
air stacking technique allows enough air to be accumulated in the lungs to generate an
acceptable cough peak flow (CPF). Several studies have shown that the use of this technique
in patients with neuromuscular disease positively impacts the biomechanical components of
peak expiratory flow (PEF) and CPF. This study aimed to evaluate the effectiveness, safety
and feasibility of the air stacking technique application and its effect on PEF and CPF
during the postoperative period in patients undergoing elective noncardiac intrathoracic
surgery We conducted an interventional experimental study involving hospitalized patients for
thoracic surgery in a teaching hospital. The study was approved by the Ethics Committee in
Human Research (42693015.0.000.5505), and the patients freely signed an informed consent form
prior to participation. Maximal inspiratory and expiratory pressure (MIP and MEP) were
measured with a previously calibrated aneroid manometer (GER-AR®), ranging from 5 to ± 300
cmH2O. A mouthpiece was attached to the manovacuometer, and the nasal clip was used during
the maneuvers following previous recommendations. (12) For maximal inspiratory and expiratory
pressures assessment, maximum effort was requested from the residual volume and total lung
capacity, respectively. Results were compared to predicted values according to the equation
proposed by Neder et al. PEF and CPF were measured with a peak flow meter ranging from 100 to
900 L/min following the literature recommendations. The patient remained seated at 90º with a
nasal clip and was asked to force maximum expiration as fast as he could through the
mouthpiece after maximum inspiration to measure PEF. To measure cough peak flow, the patient
repeated the inspiratory maneuver and was asked to cough as hard as he could. At least three
measurements of both variables were performed, provided that the last measurement was not
higher than others. The highest obtained value was considered as the result. To perform the
air stacking technique, an air manual breathing unit (AMBU) was used, attached to a
unidirectional valve and nasal/oral mask. The technique was performed with the patient in a
sitting position, head resting on a smooth surface to avoid neck hyperextension. The mask was
fit to the patient's face, and the AMBU one-way valve was kept closed. For each AMBU manual
compression (three in the total), the patient was instructed to breathe in deeply and hold
the air inside the lungs. Immediately after the first manual compression, the second and
third were performed while the patient is deep breathing in together, without exhaling the
air. PEF was measured immediately after the technique. The patient rested for 5 minutes, and
the air staking technique was repeated. The same procedure was performed to measure CPF
followed by a clinical evaluation including vital signs, visual lung expansion and
auscultation, dyspnea, and pain evaluation. Sample size calculation was based on previous
study performed by Brito et al. A minimum difference of 4% and a maximum difference of 47%
were found between PEF and CPF means before and after air stacking technique. Considering a
power of 90% and an alpha error of 5%, a power analysis revealed that a minimum number of 17
patients should be included in the study.
