<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/NCT03291119</url>
  </required_header>
  <id_info>
    <org_study_id>CVJ-RISK</org_study_id>
    <secondary_id>NK/3172/Res/97</secondary_id>
    <nct_id>NCT03291119</nct_id>
  </id_info>
  <brief_title>Risk Predictors of Extubation Failure for Cervico-medullary Junction Surgery</brief_title>
  <acronym>CVJ-RISK</acronym>
  <official_title>To Evaluate the Predictors of Risk Factors for Extubation Failure After Cervico-Vertebral Junction Surgery-A Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>Yes</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>
      CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis, and disturbance&#xD;
      of the cerebrospinal fluid circulation and blood supply. The patients undergoing surgeries on&#xD;
      CVJ might develop airway complications in immediate postoperative period warranting urgent&#xD;
      reintubation or emergency tracheostomy. Reintubation is usually difficult in immediate&#xD;
      postoperative period due the fixation of cervical spine and gross upper airway oedema due to&#xD;
      prolonged surgery in prone position. This will be the first prospective observational study&#xD;
      to find out the risk factors related to patient, anaesthesia, radiological findings and&#xD;
      surgical procedure to predict extubation failure in patients undergoing CVJ surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Query We conducted a pilot study and found that the incidence of reintubation is&#xD;
      20%. Reintubation poses a clinical, psychological and financial burden on the patients.&#xD;
      Consequently, our study aims to identify the various risk factors to predict the need for&#xD;
      reintubation and postoperative mechanical ventilation so that success of extubation can be&#xD;
      anticipated.&#xD;
&#xD;
      Introduction:&#xD;
&#xD;
      The craniovertebral junction (CVJ) includes the basiocciput, atlas, axis and various&#xD;
      supporting ligaments. The contents enclosed in CVJ include Medulla, cervical spinal cord&#xD;
      (cervico-medullary junction), spinal arteries, and lower cranial and cervical nerves1. CVJ&#xD;
      anomalies affecting skeleton might lead to the pressure on the neuraxis and disturbance of&#xD;
      the cerebrospinal fluid circulation and blood supply. The clinical manifestations of CVJ&#xD;
      abnormalities include weakness of both upper and lower limbs, respiratory dysfunction due to&#xD;
      compression of the respiratory centres in brainstem and weakness of respiratory muscles&#xD;
      including diaphragm2. The patients undergoing surgeries on CVJ might develop airway&#xD;
      complications in immediate postoperative period warranting urgent reintubation or emergency&#xD;
      tracheostomy3. Reintubation is usually difficult in immediate postoperative period in the&#xD;
      view of fixation of cervical spine and gross upper airway oedema due to prolonged surgery in&#xD;
      prone position4,5. To avoid such airway emergencies few centres favour to delay the&#xD;
      extubation. The patients with weak respiratory muscles and poor respiratory reserve tend to&#xD;
      develop major pulmonary complications and become ventilator dependant so, we always plan an&#xD;
      early weaning and extubation6-9.&#xD;
&#xD;
      Epstein et al10 reported that the potential risk factors associated with postoperative&#xD;
      emergency airway management following cervical spine surgery included; obesity (&gt;220 ponds),&#xD;
      surgery duration greater than 10 hours, anterior corpectomy with fusion of second cervical&#xD;
      vertebra, greater than 4 units of transfused blood, asthma, advanced age (&gt;65 years), a&#xD;
      cerebrospinal fluid fistula, extent surgery, and severe preoperative neurologic deficit.&#xD;
      These risk factors are generalised for all cervical surgeries. CVJ is an important area where&#xD;
      most of the vital centres present in medulla are at risk of injuries that leads to central&#xD;
      respiratory depression and even sudden death. These patients can have airway and respiratory&#xD;
      compromise even in the absence of the risk factors described by Epstein et al10. Hence, we&#xD;
      plan to conduct this study to identify the risk factors leading to extubation failure in&#xD;
      patients undergoing surgeries for CVJ anomalies, so that, early or delayed extubation can be&#xD;
      planned before the end of surgery.&#xD;
&#xD;
      NOVELTY:&#xD;
&#xD;
      This will be the first prospective observational study to find out the risk factors related&#xD;
      to patient, anaesthesia, radiological findings and surgical procedure to predict extubation&#xD;
      failure in patients undergoing CVJ surgeries. This will help in planning and predicting&#xD;
      postsurgical extubation and psychological preparation of the patients who will need&#xD;
      postoperative mechanical ventilation.&#xD;
&#xD;
      Relevance of Research Proposal to Public Health and in Given Area:&#xD;
&#xD;
      Both extubation failure and ventilatory dependence are the common problems and contribute&#xD;
      significantly to the mortality and morbidities in the patients with CVJ surgeries. Till date&#xD;
      we do not have specific parameters to predict the risk of extubation failure resulting in&#xD;
      life threatening emergency situation during extubation of these patients. With this research,&#xD;
      we might find certain risk factor that can clearly predict extubation failure and patients&#xD;
      with those risk factors can be electively ventilated or tracheostomised.&#xD;
&#xD;
      Review of Literature The CVJ anomalies might lead to the compression on the vital neural&#xD;
      structures and disturbance in cerebrospinal fluid circulation and blood supply1. These&#xD;
      patients manifest with the weakness of both upper and lower limbs, respiratory muscles&#xD;
      weakness or central suppression of ventilation2. These surgeries on CVJ might lead to airway&#xD;
      complications in immediate postoperative period warranting urgent reintubation or emergency&#xD;
      tracheostomy3. Reintubation is usually difficult in immediate postoperative period in the&#xD;
      view of fixation of cervical spine and gross upper airway oedema due to prolonged surgery in&#xD;
      prone position4,5. To avoid such airway emergencies few centres favour to delay the&#xD;
      extubation. The patients with weak respiratory muscles and poor respiratory reserve tend to&#xD;
      develop major pulmonary complications and become ventilator dependant so, we always plan an&#xD;
      early weaning and extubation6-9.&#xD;
&#xD;
      National data on the CVJ surgeries Marda et al10 hypothesize that the respiratory system is&#xD;
      compromised and sub-clinical manifestations may get aggravated postoperatively due to the&#xD;
      anesthetic or surgical reasons. They evaluated the incidence of postoperative pulmonary&#xD;
      complications (PPCs) and associated risk factors in patients undergoing combined procedure&#xD;
      for transoral odontoidectomy (TOO) and posterior fixation (PF). The authors concluded that&#xD;
      the patients with CVJ anomaly are at increased risk of developing PPCs and there is a strong&#xD;
      association between intraoperative blood transfusion and PPCs. They also found that the&#xD;
      patients PPCs had a longer ICU and hospital stay.&#xD;
&#xD;
      In another study, Marda et al11 compared the early and late extubation following transoral&#xD;
      odontoidectomy and posterior fixation. They concluded that ventilation and oxygenation was&#xD;
      comparable between the groups but the duration of ICU and hospital stay was prolonged in the&#xD;
      delayed extubation group.&#xD;
&#xD;
      Reddy et al12 evaluated the pulmonary function after surgery for congenital atlantoaxial&#xD;
      dislocation and compared with compressive myelopathy and cerebellar surgeries. The authors&#xD;
      concluded that a significant deterioration of pulmonary function that persists till one week&#xD;
      after surgery for congenital AAD and this deterioration was significantly higher than that&#xD;
      seen after surgeries for compressive myelopathies and cerebellar lesion.&#xD;
&#xD;
      International Data on the CVJ surgeries Epstein et al13 reported that the potential risk&#xD;
      factors associated with postoperative emergency airway management following cervical spine&#xD;
      surgery included; obesity (&gt;220 ponds), surgery duration greater than 10 hours, anterior&#xD;
      corpectomy with fusion of second cervical vertebra, greater than 4 units of transfused blood,&#xD;
      asthma, advanced age (&gt;65 years), a cerebrospinal fluid fistula, extent surgery, and severe&#xD;
      preoperative neurologic deficit.&#xD;
&#xD;
      These risk factors are generalised for all cervical surgeries. CVJ is an important area where&#xD;
      most of the vital centres present in medulla are at risk of injuries that leads to central&#xD;
      respiratory depression and even sudden death. These patients can have airway and respiratory&#xD;
      compromise even in the absence of the risk factors described by Epstein et al13. Hence, we&#xD;
      plan to conduct this study to identify the risk factors leading to extubation failure in&#xD;
      patients undergoing surgeries for CVJ anomalies, so that, early or delayed extubation can be&#xD;
      planned before the end of surgery.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate the predictors of extubation failure in patients undergoing surgeries for CVJ&#xD;
      anomalies.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To determine the association of various predictors with&#xD;
&#xD;
        1. Duration of postoperative mechanical ventilation&#xD;
&#xD;
        2. Duration of ICU stay&#xD;
&#xD;
        3. Duration of Hospital Stay&#xD;
&#xD;
        4. mortality&#xD;
&#xD;
      Preliminary work: We have done 10 pilot cases that shows reintubation rate of 20%. Rest of&#xD;
      the data is yet to be analysed.&#xD;
&#xD;
      Research Design/Methodology:&#xD;
&#xD;
      This Prospective Observational study will be commenced after taking approval from&#xD;
      Institutional Ethics committee and patients consent. A total of hundred patients will be&#xD;
      enrolled.&#xD;
&#xD;
      Inclusion Criterion:&#xD;
&#xD;
      Patients with CVJ Anomalies posted for surgery&#xD;
&#xD;
      Exclusion Criterion:&#xD;
&#xD;
        1. Patients requiring preoperative intubation and ventilator support&#xD;
&#xD;
        2. Patients with&#xD;
&#xD;
             1. Severe cardiac and pulmonary disease&#xD;
&#xD;
             2. Morbid obesity&#xD;
&#xD;
             3. Obstructive sleep apnoea&#xD;
&#xD;
             4. Clinically significant scoliosis&#xD;
&#xD;
             5. Severe neurological disability The &quot;Extubation Failure&quot; will be defined as&#xD;
                inability to extubate within 24 hours or reintubation within 24 hours. Early&#xD;
                extubation failure will be reintubation within 6 hours postoperatively and late&#xD;
                extubation failure will be after 6 hours postoperatively.&#xD;
&#xD;
      The criteria for reintubation will include desaturation (PaO2 &lt;60), hypoventilation (PaCO2&#xD;
      &gt;50), tachypnea (RR &gt;35/min), impending respiratory failure, stridor and retention of&#xD;
      secretion.&#xD;
&#xD;
      Besides routine preoperative investigations respiratory reserve will be evaluated by room air&#xD;
      Arterial Blood Gas analysis, Pulmonary function tests, Chest expansion and Breath holding&#xD;
      time. These parameters will be repeated after 3 months on follow up. Neurological status will&#xD;
      be assessed by using Benzel's modification of Japanese Orthopedic Association scoring system&#xD;
      (mJOA score) 11 (Annexure-I).&#xD;
&#xD;
      Standard fasting protocol will be followed. Anaesthesia and intubation techniques and&#xD;
      monitoring will be as per attending anaesthesiologist's discretion but records of these&#xD;
      techniques will be kept.&#xD;
&#xD;
      The following intraoperative clinical parameters will be recorded:&#xD;
&#xD;
        -  Hemodynamic instability&#xD;
&#xD;
        -  Total blood loss&#xD;
&#xD;
        -  Amount and type of intravenous fluids&#xD;
&#xD;
        -  Blood and blood products transfusion&#xD;
&#xD;
        -  Total blood loss&#xD;
&#xD;
        -  Intraoperative complications such as vascular injuries/Dural tear Radiological&#xD;
           abnormalities and dislocation axis will be noted. At the end of surgery patient will be&#xD;
           reversed and assessed for possibility of extubation. Postoperative status will be&#xD;
           evaluated. Patient will be followed up till discharge for any cardio-pulmonary events&#xD;
           and three months later for assessment of pulmonary reserve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.</measure>
    <time_frame>1 year</time_frame>
    <description>Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The association of various predictors with Outcome will be determined</measure>
    <time_frame>1 year</time_frame>
    <description>Outcome is defined as Duration of hospital stay</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cervical Lesion</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CVJ Anomalies posted for surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Lists of Inclusion Criterion&#xD;
&#xD;
        1.Patients with CVJ Anomalies posted for surgery&#xD;
&#xD;
        Lists of Exclusion Criterion:&#xD;
&#xD;
          1. Patients requiring preoperative intubation and ventilator support&#xD;
&#xD;
          2. Patients with Severe cardiac and pulmonary disease, Morbid obesity, Obstructive sleep&#xD;
             apnoea, Clinically significant scoliosis, Severe neurological disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kiran Jangra, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kiran Jangra, DM</last_name>
    <phone>0091-9914844330</phone>
    <email>drkiransharma0117@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hemant Bhagat, DM</last_name>
    <phone>0091-7087009529</phone>
    <email>hembhagat@rediffmail.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Kiran Jangra</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Cervico-medullary, Extubation Failure, Risk Predictors</keyword>
  <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/NCT03291119
org study id: CVJ-RISK
secondary id: NK/3172/Res/97
nct id: NCT03291119
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis, and disturbance
      of the cerebrospinal fluid circulation and blood supply. The patients undergoing surgeries on
      CVJ might develop airway complications in immediate postoperative period warranting urgent
      reintubation or emergency tracheostomy. Reintubation is usually difficult in immediate
      postoperative period due the fixation of cervical spine and gross upper airway oedema due to
      prolonged surgery in prone position. This will be the first prospective observational study
      to find out the risk factors related to patient, anaesthesia, radiological findings and
      surgical procedure to predict extubation failure in patients undergoing CVJ surgeries.
Research Query We conducted a pilot study and found that the incidence of reintubation is
      20%. Reintubation poses a clinical, psychological and financial burden on the patients.
      Consequently, our study aims to identify the various risk factors to predict the need for
      reintubation and postoperative mechanical ventilation so that success of extubation can be
      anticipated.

      Introduction:

      The craniovertebral junction (CVJ) includes the basiocciput, atlas, axis and various
      supporting ligaments. The contents enclosed in CVJ include Medulla, cervical spinal cord
      (cervico-medullary junction), spinal arteries, and lower cranial and cervical nerves1. CVJ
      anomalies affecting skeleton might lead to the pressure on the neuraxis and disturbance of
      the cerebrospinal fluid circulation and blood supply. The clinical manifestations of CVJ
      abnormalities include weakness of both upper and lower limbs, respiratory dysfunction due to
      compression of the respiratory centres in brainstem and weakness of respiratory muscles
      including diaphragm2. The patients undergoing surgeries on CVJ might develop airway
      complications in immediate postoperative period warranting urgent reintubation or emergency
      tracheostomy3. Reintubation is usually difficult in immediate postoperative period in the
      view of fixation of cervical spine and gross upper airway oedema due to prolonged surgery in
      prone position4,5. To avoid such airway emergencies few centres favour to delay the
      extubation. The patients with weak respiratory muscles and poor respiratory reserve tend to
      develop major pulmonary complications and become ventilator dependant so, we always plan an
      early weaning and extubation6-9.

      Epstein et al10 reported that the potential risk factors associated with postoperative
      emergency airway management following cervical spine surgery included; obesity (>220 ponds),
      surgery duration greater than 10 hours, anterior corpectomy with fusion of second cervical
      vertebra, greater than 4 units of transfused blood, asthma, advanced age (>65 years), a
      cerebrospinal fluid fistula, extent surgery, and severe preoperative neurologic deficit.
      These risk factors are generalised for all cervical surgeries. CVJ is an important area where
      most of the vital centres present in medulla are at risk of injuries that leads to central
      respiratory depression and even sudden death. These patients can have airway and respiratory
      compromise even in the absence of the risk factors described by Epstein et al10. Hence, we
      plan to conduct this study to identify the risk factors leading to extubation failure in
      patients undergoing surgeries for CVJ anomalies, so that, early or delayed extubation can be
      planned before the end of surgery.

      NOVELTY:

      This will be the first prospective observational study to find out the risk factors related
      to patient, anaesthesia, radiological findings and surgical procedure to predict extubation
      failure in patients undergoing CVJ surgeries. This will help in planning and predicting
      postsurgical extubation and psychological preparation of the patients who will need
      postoperative mechanical ventilation.

      Relevance of Research Proposal to Public Health and in Given Area:

      Both extubation failure and ventilatory dependence are the common problems and contribute
      significantly to the mortality and morbidities in the patients with CVJ surgeries. Till date
      we do not have specific parameters to predict the risk of extubation failure resulting in
      life threatening emergency situation during extubation of these patients. With this research,
      we might find certain risk factor that can clearly predict extubation failure and patients
      with those risk factors can be electively ventilated or tracheostomised.

      Review of Literature The CVJ anomalies might lead to the compression on the vital neural
      structures and disturbance in cerebrospinal fluid circulation and blood supply1. These
      patients manifest with the weakness of both upper and lower limbs, respiratory muscles
      weakness or central suppression of ventilation2. These surgeries on CVJ might lead to airway
      complications in immediate postoperative period warranting urgent reintubation or emergency
      tracheostomy3. Reintubation is usually difficult in immediate postoperative period in the
      view of fixation of cervical spine and gross upper airway oedema due to prolonged surgery in
      prone position4,5. To avoid such airway emergencies few centres favour to delay the
      extubation. The patients with weak respiratory muscles and poor respiratory reserve tend to
      develop major pulmonary complications and become ventilator dependant so, we always plan an
      early weaning and extubation6-9.

      National data on the CVJ surgeries Marda et al10 hypothesize that the respiratory system is
      compromised and sub-clinical manifestations may get aggravated postoperatively due to the
      anesthetic or surgical reasons. They evaluated the incidence of postoperative pulmonary
      complications (PPCs) and associated risk factors in patients undergoing combined procedure
      for transoral odontoidectomy (TOO) and posterior fixation (PF). The authors concluded that
      the patients with CVJ anomaly are at increased risk of developing PPCs and there is a strong
      association between intraoperative blood transfusion and PPCs. They also found that the
      patients PPCs had a longer ICU and hospital stay.

      In another study, Marda et al11 compared the early and late extubation following transoral
      odontoidectomy and posterior fixation. They concluded that ventilation and oxygenation was
      comparable between the groups but the duration of ICU and hospital stay was prolonged in the
      delayed extubation group.

      Reddy et al12 evaluated the pulmonary function after surgery for congenital atlantoaxial
      dislocation and compared with compressive myelopathy and cerebellar surgeries. The authors
      concluded that a significant deterioration of pulmonary function that persists till one week
      after surgery for congenital AAD and this deterioration was significantly higher than that
      seen after surgeries for compressive myelopathies and cerebellar lesion.

      International Data on the CVJ surgeries Epstein et al13 reported that the potential risk
      factors associated with postoperative emergency airway management following cervical spine
      surgery included; obesity (>220 ponds), surgery duration greater than 10 hours, anterior
      corpectomy with fusion of second cervical vertebra, greater than 4 units of transfused blood,
      asthma, advanced age (>65 years), a cerebrospinal fluid fistula, extent surgery, and severe
      preoperative neurologic deficit.

      These risk factors are generalised for all cervical surgeries. CVJ is an important area where
      most of the vital centres present in medulla are at risk of injuries that leads to central
      respiratory depression and even sudden death. These patients can have airway and respiratory
      compromise even in the absence of the risk factors described by Epstein et al13. Hence, we
      plan to conduct this study to identify the risk factors leading to extubation failure in
      patients undergoing surgeries for CVJ anomalies, so that, early or delayed extubation can be
      planned before the end of surgery.

      Objectives:

      Primary Objective:

      To evaluate the predictors of extubation failure in patients undergoing surgeries for CVJ
      anomalies.

      Secondary Objective:

      To determine the association of various predictors with

        1. Duration of postoperative mechanical ventilation

        2. Duration of ICU stay

        3. Duration of Hospital Stay

        4. mortality

      Preliminary work: We have done 10 pilot cases that shows reintubation rate of 20%. Rest of
      the data is yet to be analysed.

      Research Design/Methodology:

      This Prospective Observational study will be commenced after taking approval from
      Institutional Ethics committee and patients consent. A total of hundred patients will be
      enrolled.

      Inclusion Criterion:

      Patients with CVJ Anomalies posted for surgery

      Exclusion Criterion:

        1. Patients requiring preoperative intubation and ventilator support

        2. Patients with

             1. Severe cardiac and pulmonary disease

             2. Morbid obesity

             3. Obstructive sleep apnoea

             4. Clinically significant scoliosis

             5. Severe neurological disability The "Extubation Failure" will be defined as
                inability to extubate within 24 hours or reintubation within 24 hours. Early
                extubation failure will be reintubation within 6 hours postoperatively and late
                extubation failure will be after 6 hours postoperatively.

      The criteria for reintubation will include desaturation (PaO2 <60), hypoventilation (PaCO2
      >50), tachypnea (RR >35/min), impending respiratory failure, stridor and retention of
      secretion.

      Besides routine preoperative investigations respiratory reserve will be evaluated by room air
      Arterial Blood Gas analysis, Pulmonary function tests, Chest expansion and Breath holding
      time. These parameters will be repeated after 3 months on follow up. Neurological status will
      be assessed by using Benzel's modification of Japanese Orthopedic Association scoring system
      (mJOA score) 11 (Annexure-I).

      Standard fasting protocol will be followed. Anaesthesia and intubation techniques and
      monitoring will be as per attending anaesthesiologist's discretion but records of these
      techniques will be kept.

      The following intraoperative clinical parameters will be recorded:

        -  Hemodynamic instability

        -  Total blood loss

        -  Amount and type of intravenous fluids

        -  Blood and blood products transfusion

        -  Total blood loss

        -  Intraoperative complications such as vascular injuries/Dural tear Radiological
           abnormalities and dislocation axis will be noted. At the end of surgery patient will be
           reversed and assessed for possibility of extubation. Postoperative status will be
           evaluated. Patient will be followed up till discharge for any cardio-pulmonary events
           and three months later for assessment of pulmonary reserve.
observational model: Cohort
time perspective: Prospective
measure: Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.
time frame: 1 year
description: Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.
measure: The association of various predictors with Outcome will be determined
time frame: 1 year
description: Outcome is defined as Duration of hospital stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kiran Jangra, DM
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
last name: Kiran Jangra, DM
phone: 0091-9914844330
email: drkiransharma0117@gmail.com
last name: Hemant Bhagat, DM
phone: 0091-7087009529
email: hembhagat@rediffmail.com
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Kiran Jangra
investigator title: Principle Investigator
sharing ipd: No