Respiratory Interventions - National Institutes of Health
Airway Clearance and Secretion Mobilization DevicesDevice Type (check all that apply): FORMCHECKBOX Mechanical In-Exsuffulator [complete section A] FORMCHECKBOX Manual Cough Assist (“Heimlich” style maneuver) [complete section B] FORMCHECKBOX Therapy: Manual Percussion: Palm cups, hands, electric precussor [complete section C] FORMCHECKBOX Therapy, Postural Drainage [complete section D] FORMCHECKBOX Lung Volume Recruitment [complete section E] FORMCHECKBOX High Frequency Chest Wall Oscillation System (Percussion Vest) [complete section F] FORMCHECKBOX Intrapulmonary Percussive Ventilation or MetaNeb [complete section G] FORMCHECKBOX Other, specify (device brand and model) / [complete section H]:Answer the sections below that correspond to the Device Types indicated in question 1. Section A: Mechanical In-Exsufflator (e.g. cough assist device)Frequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/daySettings:Table 1 Mechanical In-ExsufflatorInhale PressureExhale PressureInhale TimeExhale TimePause TimeCycles per sessioncmH20cmH20secsecsecsets of breathsSection B: Manual Cough Assist (“Heimlich” style maneuver)Frequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more timesSettings: Time per session (min):Section C: Therapy: Manual Percussion: Palm cups, hands, electric precussorFrequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more timesSettings: Time per session (min):Section D: Therapy: Postural DrainageFrequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more timesSettings: Time per session (min):Section E: Lung Volume RecruitmentMethod: FORMCHECKBOX Ambu bag FORMCHECKBOX IPPB FORMCHECKBOX Inflation by cough assistFrequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/daySettings: Time per session (min):Settings:Table 2 Lung Volume RecruitmentInhale PressureExhale PressureInhale TimeExhale TimePause TimeCycles per sessioncmH20cmH20secsecsecsets of breathsSection F: High Frequency Chest Wall Oscillation System (e.g. Percussion Vest)Brand of Equipment:Type of Vest Used: FORMCHECKBOX Full upper body FORMCHECKBOX Anterior wrap-type FORMCHECKBOX Other, specify:Frequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/daySettings:Table 3 High Frequency Chest Wall Oscillation SystemTime per sessionFrequency(this may be a range)minHzSection G: Intrapulmonary Percussive Ventilation or MetaNebIndicate type of Intervention: FORMCHECKBOX Percussive Ventilation FORMCHECKBOX MetaNebFrequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/day Settings:Table 4 Intrapulmonary Percussive VentilationTime per sessionMedication(s) Nebulizedmin FORMCHECKBOX Saline FORMCHECKBOX Albuterol FORMCHECKBOX Levoalbuterol FORMCHECKBOX Dornase alpha FORMCHECKBOX Ipratropium FORMCHECKBOX Budesonide FORMCHECKBOX Other, specify:Type of Liquid in IPV cup: FORMCHECKBOX Saline FORMCHECKBOX Bronchodilator + saline FORMCHECKBOX Other specify:Section H: Other Airway Clearance Method, specify: Frequency of Use: FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As needed FORMCHECKBOX Other, specify:If Daily, times per day (on average): FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/daySettings: Time per session (min):Aerosolized Medications for Airway Clearance and Secretion ManagementTable 5 Aerosolized MedicationsMedication ClassMedication NameConcentration of each unit (eg. 44 mg/puff)Dose(# of units / puffs) (eg. 2 puffs)Frequency / Day(only if Daily)Method of DeliveryFrequencyBronchodilator (e.g., albuterol, levoalbuterol, ipratropium)Data to be filled out by siteData to be filled out by siteData to be filled out by site FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/day FORMCHECKBOX Aerosol FORMCHECKBOX MDI w/spacer FORMCHECKBOX MDI w/o spacer FORMCHECKBOX Trach collar FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As neededInhaled anti-flammatory (e.g., budesonide)Data to be filled out by siteData to be filled out by siteData to be filled out by site FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/day FORMCHECKBOX Aerosol FORMCHECKBOX MDI w/spacer FORMCHECKBOX MDI w/o spacer FORMCHECKBOX Trach collar FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As neededOther aerosols (e.g., saline, bicarbonate, dornase alpha)Data to be filled out by siteData to be filled out by siteData to be filled out by site FORMCHECKBOX < 1 time/day FORMCHECKBOX 1-2 times/day FORMCHECKBOX 3 or more times/day FORMCHECKBOX Aerosol FORMCHECKBOX MDI w/spacer FORMCHECKBOX MDI w/o spacer FORMCHECKBOX Trach collar FORMCHECKBOX Daily FORMCHECKBOX Weekly FORMCHECKBOX As neededRespiratory Support/Assisted Ventilation DevicesDevice brand, specify:Device model, specify: FORMCHECKBOX Non-invasive, positive pressure (check all that apply) FORMCHECKBOX Nasal mask FORMCHECKBOX Nasal cannula/pillows FORMCHECKBOX Oral interface FORMCHECKBOX Oronasal interface FORMCHECKBOX Other, specify:Date of Initiation of non-invasive, positive pressure (y y y y / m m/d d):Age at initiation (Years [Derived variable, use Date of Birth from Demographics form]): FORMCHECKBOX Non-invasive, negative pressure (specify below) FORMCHECKBOX Cuirass FORMCHECKBOX Porta-Lung FORMCHECKBOX Pneumobelt FORMCHECKBOX Rocking Bed FORMCHECKBOX Other, specify:Date of Initiation of non-invasive, negative pressure (y y y y / m m/d d):Age at initiation (Years [Derived variable, use Date of Birth from Demographics form]): FORMCHECKBOX Invasive with Tracheostomy tubeDate of Tracheostomy (y y y y / m m/d d):Brand/Style:Size mm ID:Length mm:Cuffed? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, Inflation/Deflation Timing: FORMCHECKBOX Inflated 24 hour/ day FORMCHECKBOX Deflated 24 hour/ day FORMCHECKBOX Inflated during night, deflated during the day FORMCHECKBOX Other, specify: FORMCHECKBOX Other, specify:Ventilation mode: FORMCHECKBOX Bilevel positive pressure FORMCHECKBOX Spontaneous breathing with Timed backup (ST) FORMCHECKBOX Average Volume Assured Pressure support (AVAPS) FORMCHECKBOX Spontaneous (S) FORMCHECKBOX Timed (T) FORMCHECKBOX Automatic Servo Ventilation (Auto SV) FORMCHECKBOX Assist Control FORMCHECKBOX Pressure Control FORMCHECKBOX Volume Control FORMCHECKBOX SIMV with Pressure Support FORMCHECKBOX Pressure Control FORMCHECKBOX Volume Control FORMCHECKBOX Negative Pressure: FORMCHECKBOX Other, specify:Ventilation MeasurementsTable 6 Ventilation MeasurementsSettingsRespiratory RateIPAP/PIPPEEP/EPAPTidal VolumePressure Support (change above PEEP)Supplemental Oxygen FORMCHECKBOX Asleep FORMCHECKBOX Awake(record only if different from asleep settings)breaths/mincm H20cm H20mLcm H20L/min FORMCHECKBOX Asleep FORMCHECKBOX Awake(record only if different from asleep settings)breaths/mincm H20cm H20mLcm H20L/minFrequency of Use: FORMCHECKBOX Daily FORMCHECKBOX As neededSchedule of Use:Hours per day: FORMCHECKBOX Night (during sleep) FORMCHECKBOX Intermittent Day time and continuous at night FORMCHECKBOX Continuous FORMCHECKBOX Intermittent with acute illnessesOxygenMethod of Administration: FORMCHECKBOX Trach collar FORMCHECKBOX Nasal Cannula FORMCHECKBOX Trans tracheal O2 FORMCHECKBOX Bipap or Ventilator FORMCHECKBOX Face mask FORMCHECKBOX Other, specify:Flow Rate (L/minute):Frequency of Use: FORMCHECKBOX Daily (continuously or intermittent) FORMCHECKBOX As neededSchedule of Use: FORMCHECKBOX Intermittent FORMCHECKBOX ContinuousHours per day:Other relevant therapies for respiratory system (e.g. physical therapy related to respiration, aquatic therapy):General InstructionsThis CRF contains data that would be collected when a pulmonary study is performed studying gas exchange.Important note: None of the data elements included on this CRF Module are classified as Core (i.e., strongly recommended for pediatric neuromuscular disease clinical studies to collect if neuromuscular disease studies are performed). All data elements are classified as supplemental (i.e., non Core) and should only be collected if the research team considers them appropriate for their study. Please see the Data Dictionary for element classifications.Specific InstructionsPlease see the Data Dictionary for definitions for each of the data elements included in this CRF Module.The CRF includes all instructions available for the data elements at this time. More detailed instructions will be added in Version 4.0 of this CRF Module. ................
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