Cervical LesionCVJ-RISKNCT03291119
Risk Predictors of Extubation Failure for Cervico-medullary Junction Surgery
An observational study of Cervical Lesion, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Lesion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CVJ Anomalies posted for surgery
Lists of Inclusion Criterion
1.Patients with CVJ Anomalies posted for surgery
Lists of Exclusion Criterion:
- Patients requiring preoperative intubation and ventilator support
- Patients with Severe cardiac and pulmonary disease, Morbid obesity, Obstructive sleep apnoea, Clinically significant scoliosis, Severe neurological disability
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Evaluate the Predictors of Risk Factors for Extubation Failure After Cervico-Vertebral Junction Surgery-A Prospective Observational Study.
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.
Read the detailed description
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
- Duration of postoperative mechanical ventilation
- Duration of ICU stay
- Duration of Hospital Stay
- 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:
- Patients requiring preoperative intubation and ventilator support
- Patients with
- Severe cardiac and pulmonary disease
- Morbid obesity
- Obstructive sleep apnoea
- Clinically significant scoliosis
- 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.
- Conditions
- Cervical Lesion
- Keywords
- Cervico-medullary, Extubation Failure, Risk Predictors
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.
Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.
Measured: 1 year
Secondary outcomes (1)
The association of various predictors with Outcome will be determined
Outcome is defined as Duration of hospital stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start31 Oct 2017 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Jangra, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Kiran Jangra, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291119
- Sponsor's protocol ID
- CVJ-RISK
- Other IDs
- NK/3172/Res/97
- Acronym
- CVJ-RISK
- Status last verified
- Sep 2017
- First submitted
- 6 Mar 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Predictors of Risk Factors for Extubation Failure After Cervico-Vertebral Junction Surgery-A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03291119
- Acronym / sponsor ID
- CVJ-RISK / CVJ-RISK
- Conditions
- Cervical Lesion
- Keywords
- Cervico-medullary, Extubation Failure, Risk Predictors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 31 Oct 2017 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Duration of postoperative mechanical ventilation
- Duration of ICU stay
- Duration of Hospital Stay
- 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:
- Patients requiring preoperative intubation and ventilator support
- Patients with
- Severe cardiac and pulmonary disease
- Morbid obesity
- Obstructive sleep apnoea
- Clinically significant scoliosis
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CVJ Anomalies posted for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.
Time frame: 1 year
Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.
1 secondary outcome
The association of various predictors with Outcome will be determined
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiran Jangra, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Lesion, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiran Jangra, DM (0091-9914844330, drkiransharma0117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.