An interventional study of Air Stacking Technique in Postoperative Care, sponsored by Universidade Cidade de Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 319 interventional studies indexed under Cough.
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Exclusion Criteria:
The air staking group
Device: Air Stacking Technique
To perform the air stacking technique, an air manual breathing unit (AMBU) was used, attached to a unidirectional valve and nasal/oral mask. For each AMBU manual compression (three in the total), the patient was instructed to breathe in deeply and hold the air inside the lungs.
Peak of expiratory flow (PEF)
PEF was measured with a peak flow meter ranging from 100 to 900 L/min (Philips Respironics®) 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
Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)
Cough peak flow (CPF)
CPF were measured with a peak flow meter ranging from 100 to 900 L/min (Philips Respironics®) 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
Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)
Maximum Inspiratory Pressure ( MIP)
MIP and MEP) were measured with a previously calibrated aneroid manovacuometer (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
Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)
Maximun Expiratory Pressure (MEP)
MIP and MEP) were measured with a previously calibrated aneroid manovacuometer (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
Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)
Plan to share: Yes — The pre operative evaluation records are available in a box kept in the private hospital specific room.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The data been available since the beginning and will be until the study publication
Access criteria: All researchers involved will have access to the hospital private room and data
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Nov 2020, 14 months.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 14 months is close to that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Universidade Cidade de Sao Paulo