<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/NCT02240901</url>
  </required_header>
  <id_info>
    <org_study_id>EHBH2013-003-005</org_study_id>
    <secondary_id>EHBHKY20I3-003-005</secondary_id>
    <nct_id>NCT02240901</nct_id>
  </id_info>
  <brief_title>A Multi-center Randomized Clinical Trial About Using LMA or ETI in Elderly Patients</brief_title>
  <acronym>LMA;ETI</acronym>
  <official_title>Effectiveness and Pulmonary Complications of Peri-Operative Laryngeal Mask Airway Used in Elderly Patients(POLMA-EP Trial): a Multi-center Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huadong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Jiading District Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Pudong New Area Gongli Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Huangpu District Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Fengxian District Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Pudong New District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The second People's Hospital of Wuxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perioperative airway management is a top priority of anesthesiologists in daily work, and&#xD;
      endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic&#xD;
      seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related&#xD;
      complications such as concomitant hemodynamic responses, damage to the oropharyngeal&#xD;
      structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the&#xD;
      anesthesia management brings new choice with invasive, lighter cardiovascular reaction and&#xD;
      many other advantages, particularly suited to short and minimally invasive surgery. But LMA&#xD;
      increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted&#xD;
      in intolerance in high airway pressure, especially in elderly patients with increased lung&#xD;
      compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the&#xD;
      occurrence of postoperative sore throat and hoarse.&#xD;
&#xD;
      To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety of&#xD;
      LMA in elderly patients. The investigators protocol will focus on the incidence of&#xD;
      postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction 1.1 Background It is essential for peri-operative patients to ensure airway&#xD;
      patency and effective ventilation, and respiratory is the most important task in&#xD;
      anesthesiologist's daily work. Endotracheal intubation(ETI) is the gold standard for&#xD;
      maintenance patients' ventilation in general anesthesia. It can effectively send narcotic gas&#xD;
      into the trachea and allow oxygen ventilation well controlled. However, ETI-related&#xD;
      complications such as dental and oral soft tissue injury, intubation and extubation related&#xD;
      cardiovascular reactions, hinder its application in some special populations such as elderly&#xD;
      patients. Clinical application of laryngeal mask airway (LMA) has brought new options and new&#xD;
      ideas for anesthesia management. LMA has the advantage of light damage, small trauma, simple&#xD;
      operation and minor cardiovascular response, and it is especially suitable for airway control&#xD;
      of patient in short and minimally invasive operation. In recent years, the application of LMA&#xD;
      has a greater proportion compared with ETI in some areas. But with LMA application&#xD;
      increasing, more and more problems have been reported.&#xD;
&#xD;
      LMA has a greater risk of gastrointestinal reflux and aspiration, because of its inadequate&#xD;
      airway tightness. For the same reason, LMA is of intolerance to high airway pressure, and&#xD;
      this may lead to hypoventilation in elderly patients with lung compliance or increased airway&#xD;
      resistance. At the same time the LMA can't completely prevent incidence of postoperative sore&#xD;
      throat and hoarseness. Therefore, it is necessary to carry out a multi-center clinical trial&#xD;
      to clarify the peri-operative advantages and disadvantages of LMA to elderly patients, to&#xD;
      preliminary explore the LMA complications occurred in elderly patients using predictive&#xD;
      models, and to clarify the safety of the LMA in airway support of elderly patients.&#xD;
&#xD;
      1.2 Research Aims The aim of the present research is to study the effects of LMA compared&#xD;
      with conventional ETI on elderly patients considering postoperative pulmonary complications,&#xD;
      anesthesia and recovery quality, oxygenation and airway support related complications.&#xD;
&#xD;
      1.3 Primary endpoint events Postoperative pulmonary complications before discharge. 1.4&#xD;
      Secondary endpoint events and other pre-specified outcomes 1.4.1 Mortality 1.4.2 PACU stay&#xD;
      1.4.3 Hospiitalization cost and duration 1.4.4 ICU admission and stay time (patients who meet&#xD;
      the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of&#xD;
      bed conversion are excluded, and those who should have been out of ICU are also excluded)&#xD;
      1.4.5 Treatment for PPCs 1.4.6 Blood and sputum culture&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2016</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 23, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The occurrence of postoperative pulmonary complications</measure>
    <time_frame>before discharge</time_frame>
    <description>five-category scale to assess the pulmonary outcomes: 0, no pulmonary complications 1, either one of the following: cough, minor lung atelectasis, dyspnea; 2, cough and sputum, bronchospasm, hypoxemia, atelectasis, hypercapnia; 3, pleural effusion, suspected pneumonia, diagnosed pneumonia, pneumothorax, diagnosed pneumonia, pneumothorax, non-invasive or invasive mechanical ventilation&lt;48hr 4, respiratory failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>before discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU admission rate</measure>
    <time_frame>before discharge</time_frame>
    <description>Patients who meet the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of bed conversion are excluded, and those who should have been out of ICU are also excluded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization days</measure>
    <time_frame>before discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PACU stay</measure>
    <time_frame>before discharge</time_frame>
    <description>PACU stay time collection is based on anesthesia records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood and sputum culture</measure>
    <time_frame>before discharge</time_frame>
    <description>In-hospital medical examinations and tests will be collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment for PPCs</measure>
    <time_frame>before discharge</time_frame>
    <description>Included antibiotics, anti-sputum drugs, steroids, mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>before discharge</time_frame>
    <description>Patients who meet the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of bed conversion are excluded, and those who should have been out of ICU are also excluded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospiitalization cost</measure>
    <time_frame>before discharge</time_frame>
    <description>Hospitalization cost is collected from hospital bill, regardless of patient's insurerance coverage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2900</enrollment>
  <condition>Complications</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Laryngeal mask airway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endotracheal intubation group（ETI）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal mask airway（LMA）</intervention_name>
    <description>Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative</description>
    <arm_group_label>Laryngeal mask airway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endotracheal intubation（ETI）</intervention_name>
    <description>Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative</description>
    <arm_group_label>Endotracheal intubation group（ETI）</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 70&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  BMI ≤ 35 kg/m2&#xD;
&#xD;
          -  Provision of signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  have anticipated difficult intubation&#xD;
&#xD;
          -  have a broken or unstable cervix&#xD;
&#xD;
          -  have laryngeal disease&#xD;
&#xD;
          -  are at high risk of aspiration (gastroesophageal reflux disease, full stomach)&#xD;
&#xD;
          -  are unable to cooperate for any reason, such as inability to speak or understand,&#xD;
             mental disease, or inability to go to the clinics&#xD;
&#xD;
          -  have taken experimental drugs in the preceding 3 months or joined another clinical&#xD;
             trial&#xD;
&#xD;
          -  did not provide informed consent or have withdrawn consent&#xD;
&#xD;
          -  are evaluated by the investigator as unsuitable for this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weifeng Yu, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Renji Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Patel MG, Swadia V, Bansal G. Prospective randomized comparative study of use of PLMA and ET tube for airway management in children under general anaesthesia. Indian J Anaesth. 2010 Mar;54(2):109-15. doi: 10.4103/0019-5049.63643.</citation>
    <PMID>20661347</PMID>
  </reference>
  <reference>
    <citation>Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.</citation>
    <PMID>23902482</PMID>
  </reference>
  <reference>
    <citation>Wang HE, Szydlo D, Stouffer JA, Lin S, Carlson JN, Vaillancourt C, Sears G, Verbeek RP, Fowler R, Idris AH, Koenig K, Christenson J, Minokadeh A, Brandt J, Rea T; ROC Investigators. Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest. Resuscitation. 2012 Sep;83(9):1061-6. doi: 10.1016/j.resuscitation.2012.05.018. Epub 2012 Jun 1.</citation>
    <PMID>22664746</PMID>
  </reference>
  <reference>
    <citation>Sharma R, Dua CK, Saxena KN. A randomised controlled study comparing the effects of laryngeal mask airway and endotracheal tube on early postoperative pulmonary functions. Singapore Med J. 2011 Dec;52(12):874-8.</citation>
    <PMID>22159929</PMID>
  </reference>
  <reference>
    <citation>Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.</citation>
    <PMID>21848460</PMID>
  </reference>
  <reference>
    <citation>Lerman J, Hammer GB, Verghese S, Ehlers M, Khalil SN, Betts E, Trillo R, Deutsch J; MAPS Investigators Group. Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways. Paediatr Anaesth. 2010 Jun;20(6):495-505. doi: 10.1111/j.1460-9592.2010.03305.x. Epub 2010 Apr 23.</citation>
    <PMID>20456065</PMID>
  </reference>
  <reference>
    <citation>Ferrari G, Milan A, Groff P, Pagnozzi F, Mazzone M, Molino P, Apra F. Continuous positive airway pressure vs. pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial. J Emerg Med. 2010 Nov;39(5):676-84. doi: 10.1016/j.jemermed.2009.07.042. Epub 2009 Oct 8.</citation>
    <PMID>19818574</PMID>
  </reference>
  <reference>
    <citation>Zoremba M, Aust H, Eberhart L, Braunecker S, Wulf H. Comparison between intubation and the laryngeal mask airway in moderately obese adults. Acta Anaesthesiol Scand. 2009 Apr;53(4):436-42. doi: 10.1111/j.1399-6576.2008.01882.x. Epub 2009 Feb 18.</citation>
    <PMID>19226293</PMID>
  </reference>
  <reference>
    <citation>Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.</citation>
    <PMID>19616722</PMID>
  </reference>
  <reference>
    <citation>Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, Crane S, Elliott M, Nicholl J; 3CPO Study Investigators. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non-invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technol Assess. 2009 Jul;13(33):1-106. doi: 10.3310/hta13330.</citation>
    <PMID>19615296</PMID>
  </reference>
  <reference>
    <citation>Glerant JC, Rose D, Oltean V, Dayen C, Mayeux I, Jounieaux V. Noninvasive ventilation using a mouthpiece in patients with chronic obstructive pulmonary disease and acute respiratory failure. Respiration. 2007;74(6):632-9. doi: 10.1159/000105163. Epub 2007 Jul 2.</citation>
    <PMID>17622735</PMID>
  </reference>
  <reference>
    <citation>Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.</citation>
    <PMID>23542800</PMID>
  </reference>
  <reference>
    <citation>Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.</citation>
    <PMID>22552194</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>LiqunYang</investigator_full_name>
    <investigator_title>Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Laryngeal mask airway</keyword>
  <keyword>endotracheal intubation</keyword>
  <keyword>postoperative pulmonary complications</keyword>
  <keyword>elderly patients</keyword>
  <!-- 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/NCT02240901
org study id: EHBH2013-003-005
secondary id: EHBHKY20I3-003-005
nct id: NCT02240901
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
Perioperative airway management is a top priority of anesthesiologists in daily work, and
      endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic
      seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related
      complications such as concomitant hemodynamic responses, damage to the oropharyngeal
      structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the
      anesthesia management brings new choice with invasive, lighter cardiovascular reaction and
      many other advantages, particularly suited to short and minimally invasive surgery. But LMA
      increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted
      in intolerance in high airway pressure, especially in elderly patients with increased lung
      compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the
      occurrence of postoperative sore throat and hoarse.

      To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety of
      LMA in elderly patients. The investigators protocol will focus on the incidence of
      postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly
      patients.
1. Introduction 1.1 Background It is essential for peri-operative patients to ensure airway
      patency and effective ventilation, and respiratory is the most important task in
      anesthesiologist's daily work. Endotracheal intubation(ETI) is the gold standard for
      maintenance patients' ventilation in general anesthesia. It can effectively send narcotic gas
      into the trachea and allow oxygen ventilation well controlled. However, ETI-related
      complications such as dental and oral soft tissue injury, intubation and extubation related
      cardiovascular reactions, hinder its application in some special populations such as elderly
      patients. Clinical application of laryngeal mask airway (LMA) has brought new options and new
      ideas for anesthesia management. LMA has the advantage of light damage, small trauma, simple
      operation and minor cardiovascular response, and it is especially suitable for airway control
      of patient in short and minimally invasive operation. In recent years, the application of LMA
      has a greater proportion compared with ETI in some areas. But with LMA application
      increasing, more and more problems have been reported.

      LMA has a greater risk of gastrointestinal reflux and aspiration, because of its inadequate
      airway tightness. For the same reason, LMA is of intolerance to high airway pressure, and
      this may lead to hypoventilation in elderly patients with lung compliance or increased airway
      resistance. At the same time the LMA can't completely prevent incidence of postoperative sore
      throat and hoarseness. Therefore, it is necessary to carry out a multi-center clinical trial
      to clarify the peri-operative advantages and disadvantages of LMA to elderly patients, to
      preliminary explore the LMA complications occurred in elderly patients using predictive
      models, and to clarify the safety of the LMA in airway support of elderly patients.

      1.2 Research Aims The aim of the present research is to study the effects of LMA compared
      with conventional ETI on elderly patients considering postoperative pulmonary complications,
      anesthesia and recovery quality, oxygenation and airway support related complications.

      1.3 Primary endpoint events Postoperative pulmonary complications before discharge. 1.4
      Secondary endpoint events and other pre-specified outcomes 1.4.1 Mortality 1.4.2 PACU stay
      1.4.3 Hospiitalization cost and duration 1.4.4 ICU admission and stay time (patients who meet
      the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of
      bed conversion are excluded, and those who should have been out of ICU are also excluded)
      1.4.5 Treatment for PPCs 1.4.6 Blood and sputum culture
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The occurrence of postoperative pulmonary complications
time frame: before discharge
description: five-category scale to assess the pulmonary outcomes: 0, no pulmonary complications 1, either one of the following: cough, minor lung atelectasis, dyspnea; 2, cough and sputum, bronchospasm, hypoxemia, atelectasis, hypercapnia; 3, pleural effusion, suspected pneumonia, diagnosed pneumonia, pneumothorax, diagnosed pneumonia, pneumothorax, non-invasive or invasive mechanical ventilation<48hr 4, respiratory failure.
measure: mortality
time frame: before discharge
measure: ICU admission rate
time frame: before discharge
description: Patients who meet the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of bed conversion are excluded, and those who should have been out of ICU are also excluded
measure: Hospitalization days
time frame: before discharge
measure: PACU stay
time frame: before discharge
description: PACU stay time collection is based on anesthesia records
measure: Blood and sputum culture
time frame: before discharge
description: In-hospital medical examinations and tests will be collected
measure: Treatment for PPCs
time frame: before discharge
description: Included antibiotics, anti-sputum drugs, steroids, mechanical ventilation
measure: ICU stay
time frame: before discharge
description: Patients who meet the ICU inclusion criteria are admitted into ICU, those who are admitted into ICU because of bed conversion are excluded, and those who should have been out of ICU are also excluded
measure: Hospiitalization cost
time frame: before discharge
description: Hospitalization cost is collected from hospital bill, regardless of patient's insurerance coverage
arm group label: Laryngeal mask airway
arm group type: Experimental
description: Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
arm group label: Endotracheal intubation group（ETI）
arm group type: Experimental
description: Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
intervention type: Device
intervention name: Laryngeal mask airway（LMA）
description: Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
arm group label: Laryngeal mask airway
intervention type: Device
intervention name: Endotracheal intubation（ETI）
description: Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
arm group label: Endotracheal intubation group（ETI）
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Weifeng Yu, Ph.D.
role: Study Chair
affiliation: Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine
facility: 
country: China
citation: Patel MG, Swadia V, Bansal G. Prospective randomized comparative study of use of PLMA and ET tube for airway management in children under general anaesthesia. Indian J Anaesth. 2010 Mar;54(2):109-15. doi: 10.4103/0019-5049.63643.
PMID: 20661347
citation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PMID: 23902482
citation: Wang HE, Szydlo D, Stouffer JA, Lin S, Carlson JN, Vaillancourt C, Sears G, Verbeek RP, Fowler R, Idris AH, Koenig K, Christenson J, Minokadeh A, Brandt J, Rea T; ROC Investigators. Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest. Resuscitation. 2012 Sep;83(9):1061-6. doi: 10.1016/j.resuscitation.2012.05.018. Epub 2012 Jun 1.
PMID: 22664746
citation: Sharma R, Dua CK, Saxena KN. A randomised controlled study comparing the effects of laryngeal mask airway and endotracheal tube on early postoperative pulmonary functions. Singapore Med J. 2011 Dec;52(12):874-8.
PMID: 22159929
citation: Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.
PMID: 21848460
citation: Lerman J, Hammer GB, Verghese S, Ehlers M, Khalil SN, Betts E, Trillo R, Deutsch J; MAPS Investigators Group. Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways. Paediatr Anaesth. 2010 Jun;20(6):495-505. doi: 10.1111/j.1460-9592.2010.03305.x. Epub 2010 Apr 23.
PMID: 20456065
citation: Ferrari G, Milan A, Groff P, Pagnozzi F, Mazzone M, Molino P, Apra F. Continuous positive airway pressure vs. pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial. J Emerg Med. 2010 Nov;39(5):676-84. doi: 10.1016/j.jemermed.2009.07.042. Epub 2009 Oct 8.
PMID: 19818574
citation: Zoremba M, Aust H, Eberhart L, Braunecker S, Wulf H. Comparison between intubation and the laryngeal mask airway in moderately obese adults. Acta Anaesthesiol Scand. 2009 Apr;53(4):436-42. doi: 10.1111/j.1399-6576.2008.01882.x. Epub 2009 Feb 18.
PMID: 19226293
citation: Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
PMID: 19616722
citation: Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, Crane S, Elliott M, Nicholl J; 3CPO Study Investigators. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non-invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technol Assess. 2009 Jul;13(33):1-106. doi: 10.3310/hta13330.
PMID: 19615296
citation: Glerant JC, Rose D, Oltean V, Dayen C, Mayeux I, Jounieaux V. Noninvasive ventilation using a mouthpiece in patients with chronic obstructive pulmonary disease and acute respiratory failure. Respiration. 2007;74(6):632-9. doi: 10.1159/000105163. Epub 2007 Jul 2.
PMID: 17622735
citation: Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.
PMID: 23542800
citation: Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PMID: 22552194
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: LiqunYang
investigator title: Department of Anesthesiology