xml: <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/NCT05981638</url>
    </required_header>
    <id_info>
      <org_study_id>2021-7/26</org_study_id>
      <nct_id>NCT05981638</nct_id>
    </id_info>
    <brief_title>The Effect of Mobilization on Gastric Emptying Time</brief_title>
    <official_title>Investigation of the Effect of Mobilization on Gastric Emptying Time Among Pediatric Patients Scheduled for Elective Surgery: Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uludag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uludag 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>
        ıntroduction Pulmonary aspiration under general anesthesia is a rare but serious complication&#xD;
        in healthy patients undergoing elective surgery. In the preoperative period, negative&#xD;
        metabolic, physiological, and/or psychological consequences may occur due to prolonged hunger&#xD;
        time (1). It is important to shorten the preoperative fasting period to reduce anxiety and&#xD;
        hunger, especially in pediatric patients (2).&#xD;
  &#xD;
        Material-Methods This study at Bursa Uludag University Hospital (January 2021- January 2022)&#xD;
        involved 84 ASA (American Society of Anesthesiologists) class I-III patients aged 4-11 years&#xD;
        undergoing elective urogenital surgery, with certain exclusions like gastrointestinal&#xD;
        disorders and high BMI (Body Mass Index).&#xD;
  &#xD;
        Gastric antral area (GAA) was measured with ultrasound (USG) before liquid intake and at&#xD;
        various intervals there after; 5, 10, 30, 60, 90 minutes. Patients were split into four&#xD;
        groups based on liquid (water or apple juice) and activity level (rest or mobilization).&#xD;
        Resting patients watched animations, while mobilized patients were encouraged to walk.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This prospective study was carried out at Bursa Uludag University Hospital between January&#xD;
        2021 and January 2022, following the approval of the local ethical committee (2021-7/26).&#xD;
        Eighty-four ASA class I-III patients aged 4-11 years who were scheduled for elective&#xD;
        urogenital surgery were included in the study. The parents were informed about the research,&#xD;
        both verbally and in writing, and their consent was obtained. Patients with a pathology that&#xD;
        prevents emptying in the upper gastrointestinal system, who have motility disorders in the&#xD;
        gastrointestinal system, who are under follow-up due to diabetes mellitus (DM), who can-not&#xD;
        cooperate, refuse to drink fluids or USG, do not provide consent from their families, have a&#xD;
        history of lower esophagus or gastric operation, have a history of upper gastrointestinal&#xD;
        bleeding in the last month, clinically significant hepatic or renal failure, and a BMI &gt; 35&#xD;
        kg m2 were excluded from the study.During the preoperative visit, the child's physical&#xD;
        characteristics (sex, age, weight, height, and body mass index) and initial vital parameters&#xD;
        (heart rate and noninvasive blood presure) were recorded. Oral intake was discontinued in all&#xD;
        children according to our common protocol (two hours for clear liquids; six hours for&#xD;
        semi-solid and solid foods)All patients were randomized according to a table created on a&#xD;
        computer using the closed-envelope method. It was planned such that only the surgeons knew&#xD;
        which group the randomized patients were in. The anesthesiologist who performed the USG&#xD;
        measurements did would not know which group the patient belonged to. Informed consent was&#xD;
        obtained after the study protocol was properly explained to the children in accordance with&#xD;
        their parents and age. In the clinic, clear liquids (water or apple juice) at room&#xD;
        temperature (22°C) were administered to the patients by a second anesthesiologist and clinic&#xD;
        nurse, in accordance with the group. The gastric antral area (GAA) was measured with USG just&#xD;
        before the intake of liquid (T0), at the 5th minute (T5), 10th minute (T10), 30th minute&#xD;
        (T30), 60th minute (T60), 90th minute (T90) by the anesthesiologist. This planned procedure&#xD;
        was performed on the morning of the day of the operation, at least two hours before the&#xD;
        induction of anesthesiaThe patients were grouped according to the kind of liquid (water or&#xD;
        apple juice) and physical activity (resting or mobilization). [Group WR [water+rest (n:19)],&#xD;
        Group WM [water+mobilization (n:21)], Group AR [apple juice (49.6kcal/100 ml + rest (n:23)]&#xD;
        and Group AM [apple juice (49.6kcal/100 ml) + mobilization (n:21)]]. All the clear liquids&#xD;
        were administered at a dose of 5 ml/kg. Patients in the resting groups (WR and AR); sat&#xD;
        between ultrasound examinations and watched the age-appropriate animation of their choice.&#xD;
        Age-appropriate audiovisual interventions such as cartoons and interactive games are&#xD;
        effective in reducing preoperative anxiety in children. However, the selection of audiovisual&#xD;
        interventions according to the age of the child is crucial. Patients in the mobilized group&#xD;
        (WM and AM) were encouraged to walk into the clinic and their rooms between the ultrasound&#xD;
        examinations.During USG imaging, patients were placed in a 45° semi-recumbent, right lateral&#xD;
        decubitus (RLD) position. A portable ultrasound device (Logic E® GE, Boston, MA, USA)&#xD;
        equipped with a high-frequency linear array transducer (probe 8-12 MHz) was used to obtain a&#xD;
        cross-sectional image of the gastric antrum. The gastric antrum was identified in the&#xD;
        sagittal or sagittal oblique plane in the epigastrium, along the edge of the left lobe of the&#xD;
        liver, and anterior to either the aorta or the inferior vena cava, according to the standard&#xD;
        protocol. Gastric emptying is influenced by gravity and should be faster in an upright&#xD;
        positionGAA, craniocaudal (D1) (cm) and anteroposterior (D2) (cm) of the antrum, including&#xD;
        stomach wall, in the RLD position werw calculated using real-time USG (Logic E® GE, Boston,&#xD;
        USA) linear probe (8-12 MHz) diameters. A single cross-section of the antrum was obtained in&#xD;
        the sagittal plane containing the left lobe of the liver and the aorta or inferior vena cava&#xD;
        and was considered a standard level for measuring craniocaudal and anteroposterior diameters.&#xD;
        The values of these diameters were inserted into the formula below to calculate the antral&#xD;
        GAA, which correlates with gastric volume (GAA = π × D1 × D2/4).&#xD;
  &#xD;
        A single investigator evaluated the hunger and thirst ratings of all children before drinking&#xD;
        the beverages (0 min), and at 10, 15, 30, 60, and 90 min after drinking.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">January 1, 2022</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</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>Other</primary_purpose>
      <masking>Double (Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measurement of gastric antral area change with USG within 90 minutes after clear fluid intake</measure>
      <time_frame>Baseline and after clear fluid intake at 10, 15, 30, 60, and 90 minutes</time_frame>
      <description>Ultrasonography (USG) is a non-invasive and reliable imaging method that can be used to measure stomach content. It is widely used to examine the gastric antral cross-sectional area (GAA) (cm2) in adult and pediatric patients.The purpose of this study was to investigate the effect of mobilization and the type of liquid drink (drinking water or apple juice) on gastric emptying time among pediatric patients scheduled for elective surgery.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">84</enrollment>
    <condition>Anesthesia</condition>
    <condition>Fasting</condition>
    <arm_group>
      <arm_group_label>Group WM (Water+mobilization)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients were randomized according to a table created on a computer using the closed-envelope method.Patients in the WM group (water+mobilization) were given water and mobilized</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group WR(water+rest)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the WR group (water+rest) were given water and stay in rest</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group AR(apple juice+rest)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AR group (apple juice+rest) were given apple juice and stay in rest</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group AM (apple juice+mobilization)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AM group (apple juice+mobilization) were given water and mobilized</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>group WM</intervention_name>
      <description>Patients were given 5ml/kg dose of water and patients were mobilized.</description>
      <arm_group_label>Group WM (Water+mobilization)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>group WR</intervention_name>
      <description>Patients were given 5ml/kg dose of water and patients were rest.</description>
      <arm_group_label>Group WR(water+rest)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Group AR</intervention_name>
      <description>Patients were given 5ml/kg dose of apple juice and patients were rest.</description>
      <arm_group_label>Group AR(apple juice+rest)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Group AM</intervention_name>
      <description>Patients were given 5ml/kg dose of apple juice and patients were mobilized.</description>
      <arm_group_label>Group AM (apple juice+mobilization)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA class I-III patients aged 4-11 years who were scheduled for elective urogenital&#xD;
               surgery were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with pathology that prevents emptying in the upper gastrointestinal system,&#xD;
               who have motility disorders in the gastrointestinal system, who are under follow-up&#xD;
               due to diabetes mellitus (DM), who can not cooperate, who refuse to drink fluids or&#xD;
               USG, who do not give consent from their families, who have a history of the lower&#xD;
               esophagus or gastric operation, with a history of upper gastrointestinal bleeding in&#xD;
               the last one month, clinically significant hepatic or renal failure, and a BMI &gt; 35 kg&#xD;
               m2 were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seda Cansabuncu</last_name>
      <role>Principal Investigator</role>
      <affiliation>BURSA ULUDAG UNIVERSITY HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Selcan Akesen</last_name>
      <role>Study Chair</role>
      <affiliation>BURSA ULUDAG UNIVERSITY HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Belgin Yavaşcaoğlu</last_name>
      <role>Study Chair</role>
      <affiliation>BURSA ULUDAG UNIVERSITY HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatih Çelik</last_name>
      <role>Study Chair</role>
      <affiliation>BURSA ULUDAG UNIVERSITY HOSPITAL</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bursa Uludag University</name>
        <address>
          <city>Bursa</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uludag University</investigator_affiliation>
      <investigator_full_name>Seda Cansabuncu</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>diagnostic imaging</keyword>
    <keyword>fasting</keyword>
    <keyword>anesthesia</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981638
  org study id: 2021-7/26
  nct id: NCT05981638
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  ıntroduction Pulmonary aspiration under general anesthesia is a rare but serious complication
        in healthy patients undergoing elective surgery. In the preoperative period, negative
        metabolic, physiological, and/or psychological consequences may occur due to prolonged hunger
        time (1). It is important to shorten the preoperative fasting period to reduce anxiety and
        hunger, especially in pediatric patients (2).
  
        Material-Methods This study at Bursa Uludag University Hospital (January 2021- January 2022)
        involved 84 ASA (American Society of Anesthesiologists) class I-III patients aged 4-11 years
        undergoing elective urogenital surgery, with certain exclusions like gastrointestinal
        disorders and high BMI (Body Mass Index).
  
        Gastric antral area (GAA) was measured with ultrasound (USG) before liquid intake and at
        various intervals there after; 5, 10, 30, 60, 90 minutes. Patients were split into four
        groups based on liquid (water or apple juice) and activity level (rest or mobilization).
        Resting patients watched animations, while mobilized patients were encouraged to walk.
  This prospective study was carried out at Bursa Uludag University Hospital between January
        2021 and January 2022, following the approval of the local ethical committee (2021-7/26).
        Eighty-four ASA class I-III patients aged 4-11 years who were scheduled for elective
        urogenital surgery were included in the study. The parents were informed about the research,
        both verbally and in writing, and their consent was obtained. Patients with a pathology that
        prevents emptying in the upper gastrointestinal system, who have motility disorders in the
        gastrointestinal system, who are under follow-up due to diabetes mellitus (DM), who can-not
        cooperate, refuse to drink fluids or USG, do not provide consent from their families, have a
        history of lower esophagus or gastric operation, have a history of upper gastrointestinal
        bleeding in the last month, clinically significant hepatic or renal failure, and a BMI > 35
        kg m2 were excluded from the study.During the preoperative visit, the child's physical
        characteristics (sex, age, weight, height, and body mass index) and initial vital parameters
        (heart rate and noninvasive blood presure) were recorded. Oral intake was discontinued in all
        children according to our common protocol (two hours for clear liquids; six hours for
        semi-solid and solid foods)All patients were randomized according to a table created on a
        computer using the closed-envelope method. It was planned such that only the surgeons knew
        which group the randomized patients were in. The anesthesiologist who performed the USG
        measurements did would not know which group the patient belonged to. Informed consent was
        obtained after the study protocol was properly explained to the children in accordance with
        their parents and age. In the clinic, clear liquids (water or apple juice) at room
        temperature (22°C) were administered to the patients by a second anesthesiologist and clinic
        nurse, in accordance with the group. The gastric antral area (GAA) was measured with USG just
        before the intake of liquid (T0), at the 5th minute (T5), 10th minute (T10), 30th minute
        (T30), 60th minute (T60), 90th minute (T90) by the anesthesiologist. This planned procedure
        was performed on the morning of the day of the operation, at least two hours before the
        induction of anesthesiaThe patients were grouped according to the kind of liquid (water or
        apple juice) and physical activity (resting or mobilization). [Group WR [water+rest (n:19)],
        Group WM [water+mobilization (n:21)], Group AR [apple juice (49.6kcal/100 ml + rest (n:23)]
        and Group AM [apple juice (49.6kcal/100 ml) + mobilization (n:21)]]. All the clear liquids
        were administered at a dose of 5 ml/kg. Patients in the resting groups (WR and AR); sat
        between ultrasound examinations and watched the age-appropriate animation of their choice.
        Age-appropriate audiovisual interventions such as cartoons and interactive games are
        effective in reducing preoperative anxiety in children. However, the selection of audiovisual
        interventions according to the age of the child is crucial. Patients in the mobilized group
        (WM and AM) were encouraged to walk into the clinic and their rooms between the ultrasound
        examinations.During USG imaging, patients were placed in a 45° semi-recumbent, right lateral
        decubitus (RLD) position. A portable ultrasound device (Logic E® GE, Boston, MA, USA)
        equipped with a high-frequency linear array transducer (probe 8-12 MHz) was used to obtain a
        cross-sectional image of the gastric antrum. The gastric antrum was identified in the
        sagittal or sagittal oblique plane in the epigastrium, along the edge of the left lobe of the
        liver, and anterior to either the aorta or the inferior vena cava, according to the standard
        protocol. Gastric emptying is influenced by gravity and should be faster in an upright
        positionGAA, craniocaudal (D1) (cm) and anteroposterior (D2) (cm) of the antrum, including
        stomach wall, in the RLD position werw calculated using real-time USG (Logic E® GE, Boston,
        USA) linear probe (8-12 MHz) diameters. A single cross-section of the antrum was obtained in
        the sagittal plane containing the left lobe of the liver and the aorta or inferior vena cava
        and was considered a standard level for measuring craniocaudal and anteroposterior diameters.
        The values of these diameters were inserted into the formula below to calculate the antral
        GAA, which correlates with gastric volume (GAA = π × D1 × D2/4).
  
        A single investigator evaluated the hunger and thirst ratings of all children before drinking
        the beverages (0 min), and at 10, 15, 30, 60, and 90 min after drinking.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Care Provider, Investigator)
  measure: Measurement of gastric antral area change with USG within 90 minutes after clear fluid intake
  time frame: Baseline and after clear fluid intake at 10, 15, 30, 60, and 90 minutes
  description: Ultrasonography (USG) is a non-invasive and reliable imaging method that can be used to measure stomach content. It is widely used to examine the gastric antral cross-sectional area (GAA) (cm2) in adult and pediatric patients.The purpose of this study was to investigate the effect of mobilization and the type of liquid drink (drinking water or apple juice) on gastric emptying time among pediatric patients scheduled for elective surgery.
  arm group label: Group WM (Water+mobilization)
  arm group type: Other
  description: All patients were randomized according to a table created on a computer using the closed-envelope method.Patients in the WM group (water+mobilization) were given water and mobilized
  arm group label: Group WR(water+rest)
  arm group type: Other
  description: All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the WR group (water+rest) were given water and stay in rest
  arm group label: Group AR(apple juice+rest)
  arm group type: Other
  description: All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AR group (apple juice+rest) were given apple juice and stay in rest
  arm group label: Group AM (apple juice+mobilization)
  arm group type: Other
  description: All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AM group (apple juice+mobilization) were given water and mobilized
  intervention type: Other
  intervention name: group WM
  description: Patients were given 5ml/kg dose of water and patients were mobilized.
  arm group label: Group WM (Water+mobilization)
  intervention type: Other
  intervention name: group WR
  description: Patients were given 5ml/kg dose of water and patients were rest.
  arm group label: Group WR(water+rest)
  intervention type: Other
  intervention name: Group AR
  description: Patients were given 5ml/kg dose of apple juice and patients were rest.
  arm group label: Group AR(apple juice+rest)
  intervention type: Other
  intervention name: Group AM
  description: Patients were given 5ml/kg dose of apple juice and patients were mobilized.
  arm group label: Group AM (apple juice+mobilization)
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 11 Years
  healthy volunteers: No
  last name: Seda Cansabuncu
  role: Principal Investigator
  affiliation: BURSA ULUDAG UNIVERSITY HOSPITAL
  last name: Selcan Akesen
  role: Study Chair
  affiliation: BURSA ULUDAG UNIVERSITY HOSPITAL
  last name: Belgin Yavaşcaoğlu
  role: Study Chair
  affiliation: BURSA ULUDAG UNIVERSITY HOSPITAL
  last name: Fatih Çelik
  role: Study Chair
  affiliation: BURSA ULUDAG UNIVERSITY HOSPITAL
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Uludag University
  investigator full name: Seda Cansabuncu
  investigator title: principal investigator