<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/NCT02224196</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0270</org_study_id>
    <nct_id>NCT02224196</nct_id>
  </id_info>
  <brief_title>Comparison of Peak Airway Pressure and Gastric Insufflation in Manual Ventilation and Pressure-controlled Ventilation With Facemask During Anesthesia Induction in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of peak airway pressure and gastric insufflation in manual ventilation and&#xD;
      pressure-controlled ventilation with facemask during anesthesia induction in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2014</start_date>
  <completion_date type="Actual">January 30, 2015</completion_date>
  <primary_completion_date type="Actual">January 30, 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peak airway pressure</measure>
    <time_frame>3 minutes</time_frame>
    <description>The primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>antral area of stomach</measure>
    <time_frame>3 minutes</time_frame>
    <description>All patients' antral area of stomach will be calculated by ultrasound after 3 minutes-facemask ventilation to estimate the quantity of gas insufflation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Elective Urologic Surgeries</condition>
  <arm_group>
    <arm_group_label>manual ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>pressure-controlled ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>manual ventilation</intervention_name>
    <description>Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.</description>
    <arm_group_label>manual ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pressure-controlled ventilation</intervention_name>
    <description>Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.</description>
    <arm_group_label>pressure-controlled ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA physical status with I or II&#xD;
&#xD;
          2. Those parents who signed with informed consents.&#xD;
&#xD;
          3. Children who are scheduled for elective urologic surgery (aged 6 month to 7 year)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Risk of aspiration&#xD;
&#xD;
          2. Oropharyngeal or facial anomaly&#xD;
&#xD;
          3. history of abdominal (stomach) surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology &amp; Pain Medicine, Yonsei university college of medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.</citation>
    <PMID>17122571</PMID>
  </results_reference>
  <results_reference>
    <citation>von Goedecke A, Voelckel WG, Wenzel V, Hormann C, Wagner-Berger HG, Dorges V, Lindner KH, Keller C. Mechanical versus manual ventilation via a face mask during the induction of anesthesia: a prospective, randomized, crossover study. Anesth Analg. 2004 Jan;98(1):260-263. doi: 10.1213/01.ANE.0000096190.36875.67.</citation>
    <PMID>14693633</PMID>
  </results_reference>
  <results_reference>
    <citation>Kluger MT, Visvanathan T, Myburgh JA, Westhorpe RN. Crisis management during anaesthesia: regurgitation, vomiting, and aspiration. Qual Saf Health Care. 2005 Jun;14(3):e4. doi: 10.1136/qshc.2002.004259.</citation>
    <PMID>15933301</PMID>
  </results_reference>
  <results_reference>
    <citation>Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.</citation>
    <PMID>16563326</PMID>
  </results_reference>
  <results_reference>
    <citation>Borland LM, Sereika SM, Woelfel SK, Saitz EW, Carrillo PA, Lupin JL, Motoyama EK. Pulmonary aspiration in pediatric patients during general anesthesia: incidence and outcome. J Clin Anesth. 1998 Mar;10(2):95-102. doi: 10.1016/s0952-8180(97)00250-x.</citation>
    <PMID>9524892</PMID>
  </results_reference>
  <results_reference>
    <citation>Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory mechanics, gastric insufflation pressure, and air leakage of the laryngeal mask airway. Anesth Analg. 1997 May;84(5):1025-8. doi: 10.1097/00000539-199705000-00013.</citation>
    <PMID>9141925</PMID>
  </results_reference>
  <results_reference>
    <citation>Weiler N, Heinrichs W, Dick W. Assessment of pulmonary mechanics and gastric inflation pressure during mask ventilation. Prehosp Disaster Med. 1995 Apr-Jun;10(2):101-5. doi: 10.1017/s1049023x00041807.</citation>
    <PMID>10155411</PMID>
  </results_reference>
  <results_reference>
    <citation>Seet MM, Soliman KM, Sbeih ZF. Comparison of three modes of positive pressure mask ventilation during induction of anaesthesia: a prospective, randomized, crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):913-6. doi: 10.1097/EJA.0b013e328329b0ab.</citation>
    <PMID>19390448</PMID>
  </results_reference>
  <results_reference>
    <citation>Ho-Tai LM, Devitt JH, Noel AG, O'Donnell MP. Gas leak and gastric insufflation during controlled ventilation: face mask versus laryngeal mask airway. Can J Anaesth. 1998 Mar;45(3):206-11. doi: 10.1007/BF03012903.</citation>
    <PMID>9579256</PMID>
  </results_reference>
  <results_reference>
    <citation>SNOW RG. THE MUSCLE RELAXANTS AND THE CARDIA, INCLUDING THE CLINICAL MANAGEMENT OF PATIENTS LIKELY TO VOMIT AND REGURGITATE. Br J Anaesth. 1963 Sep;35:541-5. doi: 10.1093/bja/35.9.541. No abstract available.</citation>
    <PMID>14066104</PMID>
  </results_reference>
  <results_reference>
    <citation>Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315.</citation>
    <PMID>3828180</PMID>
  </results_reference>
  <results_reference>
    <citation>Lagarde S, Semjen F, Nouette-Gaulain K, Masson F, Bordes M, Meymat Y, Cros AM. Facemask pressure-controlled ventilation in children: what is the pressure limit? Anesth Analg. 2010 Jun 1;110(6):1676-9. doi: 10.1213/ANE.0b013e3181d8a14c. Epub 2010 Apr 30.</citation>
    <PMID>20435941</PMID>
  </results_reference>
  <results_reference>
    <citation>Moynihan RJ, Brock-Utne JG, Archer JH, Feld LH, Kreitzman TR. The effect of cricoid pressure on preventing gastric insufflation in infants and children. Anesthesiology. 1993 Apr;78(4):652-6. doi: 10.1097/00000542-199304000-00007.</citation>
    <PMID>8466065</PMID>
  </results_reference>
  <results_reference>
    <citation>Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.</citation>
    <PMID>24317204</PMID>
  </results_reference>
  <results_reference>
    <citation>Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.</citation>
    <PMID>21364462</PMID>
  </results_reference>
  <results_reference>
    <citation>Schmitz A, Thomas S, Melanie F, Rabia L, Klaghofer R, Weiss M, Kellenberger C. Ultrasonographic gastric antral area and gastric contents volume in children. Paediatr Anaesth. 2012 Feb;22(2):144-9. doi: 10.1111/j.1460-9592.2011.03718.x. Epub 2011 Oct 14.</citation>
    <PMID>21999211</PMID>
  </results_reference>
  <results_reference>
    <citation>Brimacomb J, Keller C, Kurian S, Myles J. Reliability of epigastric auscultation to detect gastric insufflation. Br J Anaesth. 2002 Jan;88(1):127-9. doi: 10.1093/bja/88.1.127.</citation>
    <PMID>11881867</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>manual ventilation</keyword>
  <keyword>pressure-controlled ventilation</keyword>
  <keyword>peak airway pressure</keyword>
  <keyword>antral area</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/NCT02224196
org study id: 4-2014-0270
nct id: NCT02224196
lead sponsor: 
has dmc: No
Comparison of peak airway pressure and gastric insufflation in manual ventilation and
      pressure-controlled ventilation with facemask during anesthesia induction in children.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: peak airway pressure
time frame: 3 minutes
description: The primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.
measure: antral area of stomach
time frame: 3 minutes
description: All patients' antral area of stomach will be calculated by ultrasound after 3 minutes-facemask ventilation to estimate the quantity of gas insufflation.
arm group label: manual ventilation
arm group type: Experimental
arm group label: pressure-controlled ventilation
arm group type: Active Comparator
intervention type: Other
intervention name: manual ventilation
description: Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.
arm group label: manual ventilation
intervention type: Other
intervention name: pressure-controlled ventilation
description: Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.
arm group label: pressure-controlled ventilation
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
citation: Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PMID: 17122571
citation: von Goedecke A, Voelckel WG, Wenzel V, Hormann C, Wagner-Berger HG, Dorges V, Lindner KH, Keller C. Mechanical versus manual ventilation via a face mask during the induction of anesthesia: a prospective, randomized, crossover study. Anesth Analg. 2004 Jan;98(1):260-263. doi: 10.1213/01.ANE.0000096190.36875.67.
PMID: 14693633
citation: Kluger MT, Visvanathan T, Myburgh JA, Westhorpe RN. Crisis management during anaesthesia: regurgitation, vomiting, and aspiration. Qual Saf Health Care. 2005 Jun;14(3):e4. doi: 10.1136/qshc.2002.004259.
PMID: 15933301
citation: Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
PMID: 16563326
citation: Borland LM, Sereika SM, Woelfel SK, Saitz EW, Carrillo PA, Lupin JL, Motoyama EK. Pulmonary aspiration in pediatric patients during general anesthesia: incidence and outcome. J Clin Anesth. 1998 Mar;10(2):95-102. doi: 10.1016/s0952-8180(97)00250-x.
PMID: 9524892
citation: Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory mechanics, gastric insufflation pressure, and air leakage of the laryngeal mask airway. Anesth Analg. 1997 May;84(5):1025-8. doi: 10.1097/00000539-199705000-00013.
PMID: 9141925
citation: Weiler N, Heinrichs W, Dick W. Assessment of pulmonary mechanics and gastric inflation pressure during mask ventilation. Prehosp Disaster Med. 1995 Apr-Jun;10(2):101-5. doi: 10.1017/s1049023x00041807.
PMID: 10155411
citation: Seet MM, Soliman KM, Sbeih ZF. Comparison of three modes of positive pressure mask ventilation during induction of anaesthesia: a prospective, randomized, crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):913-6. doi: 10.1097/EJA.0b013e328329b0ab.
PMID: 19390448
citation: Ho-Tai LM, Devitt JH, Noel AG, O'Donnell MP. Gas leak and gastric insufflation during controlled ventilation: face mask versus laryngeal mask airway. Can J Anaesth. 1998 Mar;45(3):206-11. doi: 10.1007/BF03012903.
PMID: 9579256
citation: SNOW RG. THE MUSCLE RELAXANTS AND THE CARDIA, INCLUDING THE CLINICAL MANAGEMENT OF PATIENTS LIKELY TO VOMIT AND REGURGITATE. Br J Anaesth. 1963 Sep;35:541-5. doi: 10.1093/bja/35.9.541. No abstract available.
PMID: 14066104
citation: Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315.
PMID: 3828180
citation: Lagarde S, Semjen F, Nouette-Gaulain K, Masson F, Bordes M, Meymat Y, Cros AM. Facemask pressure-controlled ventilation in children: what is the pressure limit? Anesth Analg. 2010 Jun 1;110(6):1676-9. doi: 10.1213/ANE.0b013e3181d8a14c. Epub 2010 Apr 30.
PMID: 20435941
citation: Moynihan RJ, Brock-Utne JG, Archer JH, Feld LH, Kreitzman TR. The effect of cricoid pressure on preventing gastric insufflation in infants and children. Anesthesiology. 1993 Apr;78(4):652-6. doi: 10.1097/00000542-199304000-00007.
PMID: 8466065
citation: Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.
PMID: 24317204
citation: Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PMID: 21364462
citation: Schmitz A, Thomas S, Melanie F, Rabia L, Klaghofer R, Weiss M, Kellenberger C. Ultrasonographic gastric antral area and gastric contents volume in children. Paediatr Anaesth. 2012 Feb;22(2):144-9. doi: 10.1111/j.1460-9592.2011.03718.x. Epub 2011 Oct 14.
PMID: 21999211
citation: Brimacomb J, Keller C, Kurian S, Myles J. Reliability of epigastric auscultation to detect gastric insufflation. Br J Anaesth. 2002 Jan;88(1):127-9. doi: 10.1093/bja/88.1.127.
PMID: 11881867
responsible party type: Sponsor