<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458623</url>
  </required_header>
  <id_info>
    <org_study_id>AOES</org_study_id>
    <nct_id>NCT04458623</nct_id>
  </id_info>
  <brief_title>Air Test In Diagnosis Of Postoperative Lung Atelectasis</brief_title>
  <official_title>Accuracy Of Air Test In Diagnosis Of Postoperative Lung Atelectasis In Elderly Patients Undergoing Major Orthopedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pulmonary complication represent asignificant source of morbidity and have&#xD;
      greater incidence and costs than cardiac complications alone .Atelectasis is the commonest&#xD;
      one. Aelectasis may develop in nearly up to 90% of patients after general anaesthesia&#xD;
      ,persist up to several days .Oxygen therapy is usually given in the postoperative period to&#xD;
      alleviate hypoxemia. However it's usually discontinued before discharge to the ward based on&#xD;
      clinical criteria such as patients being awake with normal vital signs and no respiratory&#xD;
      distress. Available literatures suggest that it's not valid . Pulse oximetry provide accurate&#xD;
      objective measurement of oxygenation,continuous and non invasive.Recently, Fernando etal&#xD;
      2017,used pulse oximetry after 5 minutes of oxygenation to detect postoperative atelectasis,&#xD;
      the cut point was 96%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although it has been postulated that early hypoxemia lasts approximately two hours after a&#xD;
      surgical procedure, the first 20 minutes of the postoperative period seem to be most critical&#xD;
      . It is evident that the majority of transport times would fall well within this 20 minute&#xD;
      window , thus the potential for postoperative hypoxemia during the transport period does&#xD;
      exist. Canet, et al. (1989) found significant differences in oxygen saturation when&#xD;
      administering 35% oxygen to adults in the PACU after a 30 second transport while breathing&#xD;
      room air.The alveolar shunt induced by atelectasis is the main cause of oxygenation&#xD;
      impairment during postoperative period. Witting MD, Lueck CH reported the ability of pulse&#xD;
      oximetry at room air to detect hypoxemia based on 513 blood gas analysis. Coincidentially a&#xD;
      room air oxygen saturation value &lt;96% was selected a cut point of hypoxemia ( Po2 &lt;70 mmhg&#xD;
      )and moderate hypercapnia ( Pco2 &gt;50 mmhg ) . Jones and Jones descriped a digram showing&#xD;
      relationship between SPO2 and FiO2 and proved that SPO2 &lt; 96% correspond to shunt effect of&#xD;
      more than 10% and defines alveolar collapse . clark et al 2001determined time required for&#xD;
      partial pressure of arterial oxygen to reach equilibrium during mechanical ventilation after&#xD;
      a step change in fractional inspired oxygen, they reported that 5-10 minutes will be adequate&#xD;
      . Ferrando C 2017 reported The accuracy of postoperative, non-invasive Air-Test to diagnose&#xD;
      atelectasis in healthy patients after surgery They found that the air test diagnosed&#xD;
      postoperative atelectasis with sensitivity of 82% and specificity of 87% and area uder the&#xD;
      curve of 0.9 The presence of atelectasis was confirmed by CT scan in all patients with&#xD;
      positive air test and in 5 patients with negative air test .The Air-Test may represent an&#xD;
      accurate, simple, inexpensive and non-invasive method for diagnosing postoperative&#xD;
      atelectasis.Sonography is a simple, noninvasive, and radiation-free methodology which has&#xD;
      gained increasing usage in daily practice for detection of atelectasis. Sonography is a&#xD;
      radiation-free methodology which plays an important role in diagnosing pulmonary diseases&#xD;
      including obstructive and compressive atelectasis of different origins Furthermore, lung&#xD;
      ultrasound has shown reliable sensitivity and specificity for the diagnosis of&#xD;
      anaesthesia-induced atelectasis . Telectasis after general anaesthesia is basal and&#xD;
      segmental. For this,we designed this trial as a pilot to detect the accuracy (sensitivity and&#xD;
      specificity) of Air-Test to detect atelectasis in a homogenous group (elderly patients&#xD;
      undergoing orthopedic surgery) using Roc testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to assess the accuracy of air test in detecting postoperative atelectasis compared with reference ultrasonographic lung detection of atelectasis in a special grou of patients (aged) and a special form of surgery (orthopedics).</measure>
    <time_frame>30 minutes</time_frame>
    <description>using air test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Atelectasis</condition>
  <arm_group>
    <arm_group_label>positive air test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>postoperative in the recovery room.patients received supplemental oxygen through a venture mask with a jet and flow adjusted to a theoretical fio2 of 100% for 10 min. The Air-Test was then performed by removing the oxygen mask and leaving the patients breathing room air for 10 min while continuously monitoring SpO2 with a pulse oximeter finger probe. The Air-Test result was considered positive when the recorded SpO2 was ≤96%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>negative air test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>negative when SpO2 was &gt;96 %.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Air Test</intervention_name>
    <description>.The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.</description>
    <arm_group_label>negative air test</arm_group_label>
    <arm_group_label>positive air test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Age (&gt;60 years)&#xD;
&#xD;
          -  ASA I , III&#xD;
&#xD;
          -  Type of surgery: major orthopedic surgey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -Patient refusal.&#xD;
&#xD;
          -  Patients with any significant chest disease&#xD;
&#xD;
          -  Patients with any major cardiac disese&#xD;
&#xD;
          -  Morbid obese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>faculty of medicine,Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection 2014.</citation>
    <PMID>25313335</PMID>
  </reference>
  <reference>
    <citation>Moller JT, Wittrup M, Johansen SH. Hypoxemia in the postanesthesia care unit: an observer study. Anesthesiology. 1990 Nov;73(5):890-5. doi: 10.1097/00000542-199011000-00016.</citation>
    <PMID>2240679</PMID>
  </reference>
  <reference>
    <citation>Brismar B, Hedenstierna G, Lundquist H, Strandberg A, Svensson L, Tokics L. Pulmonary densities during anesthesia with muscular relaxation--a proposal of atelectasis. Anesthesiology. 1985 Apr;62(4):422-8. doi: 10.1097/00000542-198504000-00009.</citation>
    <PMID>3885791</PMID>
  </reference>
  <reference>
    <citation>Canet J, Ricos M, Vidal F. Early postoperative arterial oxygen desaturation. Determining factors and response to oxygen therapy. Anesth Analg. 1989 Aug;69(2):207-12.</citation>
    <PMID>2764289</PMID>
  </reference>
  <reference>
    <citation>Jones JG, Jones SE. Discriminating between the effect of shunt and reduced VA/Q on arterial oxygen saturation is particularly useful in clinical practice. J Clin Monit Comput. 2000;16(5-6):337-50. doi: 10.1023/a:1011495416005.</citation>
    <PMID>12580217</PMID>
  </reference>
  <reference>
    <citation>Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.</citation>
    <PMID>28554935</PMID>
  </reference>
  <reference>
    <citation>Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.</citation>
    <PMID>24662376</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Yasser Mamdouh Hassan Badawy</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458623
org study id: AOES
nct id: NCT04458623
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative pulmonary complication represent asignificant source of morbidity and have
      greater incidence and costs than cardiac complications alone .Atelectasis is the commonest
      one. Aelectasis may develop in nearly up to 90% of patients after general anaesthesia
      ,persist up to several days .Oxygen therapy is usually given in the postoperative period to
      alleviate hypoxemia. However it's usually discontinued before discharge to the ward based on
      clinical criteria such as patients being awake with normal vital signs and no respiratory
      distress. Available literatures suggest that it's not valid . Pulse oximetry provide accurate
      objective measurement of oxygenation,continuous and non invasive.Recently, Fernando etal
      2017,used pulse oximetry after 5 minutes of oxygenation to detect postoperative atelectasis,
      the cut point was 96%.
Although it has been postulated that early hypoxemia lasts approximately two hours after a
      surgical procedure, the first 20 minutes of the postoperative period seem to be most critical
      . It is evident that the majority of transport times would fall well within this 20 minute
      window , thus the potential for postoperative hypoxemia during the transport period does
      exist. Canet, et al. (1989) found significant differences in oxygen saturation when
      administering 35% oxygen to adults in the PACU after a 30 second transport while breathing
      room air.The alveolar shunt induced by atelectasis is the main cause of oxygenation
      impairment during postoperative period. Witting MD, Lueck CH reported the ability of pulse
      oximetry at room air to detect hypoxemia based on 513 blood gas analysis. Coincidentially a
      room air oxygen saturation value <96% was selected a cut point of hypoxemia ( Po2 <70 mmhg
      )and moderate hypercapnia ( Pco2 >50 mmhg ) . Jones and Jones descriped a digram showing
      relationship between SPO2 and FiO2 and proved that SPO2 < 96% correspond to shunt effect of
      more than 10% and defines alveolar collapse . clark et al 2001determined time required for
      partial pressure of arterial oxygen to reach equilibrium during mechanical ventilation after
      a step change in fractional inspired oxygen, they reported that 5-10 minutes will be adequate
      . Ferrando C 2017 reported The accuracy of postoperative, non-invasive Air-Test to diagnose
      atelectasis in healthy patients after surgery They found that the air test diagnosed
      postoperative atelectasis with sensitivity of 82% and specificity of 87% and area uder the
      curve of 0.9 The presence of atelectasis was confirmed by CT scan in all patients with
      positive air test and in 5 patients with negative air test .The Air-Test may represent an
      accurate, simple, inexpensive and non-invasive method for diagnosing postoperative
      atelectasis.Sonography is a simple, noninvasive, and radiation-free methodology which has
      gained increasing usage in daily practice for detection of atelectasis. Sonography is a
      radiation-free methodology which plays an important role in diagnosing pulmonary diseases
      including obstructive and compressive atelectasis of different origins Furthermore, lung
      ultrasound has shown reliable sensitivity and specificity for the diagnosis of
      anaesthesia-induced atelectasis . Telectasis after general anaesthesia is basal and
      segmental. For this,we designed this trial as a pilot to detect the accuracy (sensitivity and
      specificity) of Air-Test to detect atelectasis in a homogenous group (elderly patients
      undergoing orthopedic surgery) using Roc testing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: to assess the accuracy of air test in detecting postoperative atelectasis compared with reference ultrasonographic lung detection of atelectasis in a special grou of patients (aged) and a special form of surgery (orthopedics).
time frame: 30 minutes
description: using air test
arm group label: positive air test
arm group type: Active Comparator
description: postoperative in the recovery room.patients received supplemental oxygen through a venture mask with a jet and flow adjusted to a theoretical fio2 of 100% for 10 min. The Air-Test was then performed by removing the oxygen mask and leaving the patients breathing room air for 10 min while continuously monitoring SpO2 with a pulse oximeter finger probe. The Air-Test result was considered positive when the recorded SpO2 was ≤96%.
arm group label: negative air test
arm group type: Active Comparator
description: negative when SpO2 was >96 %.
intervention type: Diagnostic Test
intervention name: Air Test
description: .The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
arm group label: negative air test
arm group label: positive air test
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection 2014.
PMID: 25313335
citation: Moller JT, Wittrup M, Johansen SH. Hypoxemia in the postanesthesia care unit: an observer study. Anesthesiology. 1990 Nov;73(5):890-5. doi: 10.1097/00000542-199011000-00016.
PMID: 2240679
citation: Brismar B, Hedenstierna G, Lundquist H, Strandberg A, Svensson L, Tokics L. Pulmonary densities during anesthesia with muscular relaxation--a proposal of atelectasis. Anesthesiology. 1985 Apr;62(4):422-8. doi: 10.1097/00000542-198504000-00009.
PMID: 3885791
citation: Canet J, Ricos M, Vidal F. Early postoperative arterial oxygen desaturation. Determining factors and response to oxygen therapy. Anesth Analg. 1989 Aug;69(2):207-12.
PMID: 2764289
citation: Jones JG, Jones SE. Discriminating between the effect of shunt and reduced VA/Q on arterial oxygen saturation is particularly useful in clinical practice. J Clin Monit Comput. 2000;16(5-6):337-50. doi: 10.1023/a:1011495416005.
PMID: 12580217
citation: Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.
PMID: 28554935
citation: Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
PMID: 24662376
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Yasser Mamdouh Hassan Badawy
investigator title: principal investigator
mesh term: Pulmonary Atelectasis
sharing ipd: No