Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03291119 |
| Other study ID # |
CVJ-RISK |
| Secondary ID |
NK/3172/Res/97 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
March 6, 2017 |
| Last updated |
September 19, 2017 |
| Start date |
October 31, 2017 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
September 2017 |
| Source |
Postgraduate Institute of Medical Education and Research |
| Contact |
Kiran Jangra, DM |
| Phone |
0091-9914844330 |
| Email |
drkiransharma0117[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
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.
