The first objective of this study is to evaluate by direct laryngo-tracheoscopy the possible role of cuffed versus uncuffed tracheal tubes in producing airway injury in infants and children who were previously more than 24 hours intubated. The…
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Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters are injury or any pathology of the airway caused by
cuffed versus uncuffed endotracheal tubes after prolonged tracheal intubation,
detected by direct laryngo-tracheoscopy.
Secondary outcome
Secondary outcome parameters are other risk factors which might contribute to
airway injury in intubated children. These factors are the brand of the tube,
the route of intubation (oral or nasal), and tube size. Further factors are
prematurity, age and weight of the patient, the reason for prolonged intubation
such as cardiac failure, respiratory failure, sepsis, postoperative ventilation
or other, presence of airway infection or shock during intubation. Also adverse
events during intubation such as accidental extubation, reintubation,
hemodynamic compromise and sepsis will be recorded.
Background summary
The routine use of cuffed tubes in infants and small children has been
extensively discussed because of the potential risk of airway injury (1-3). In
the past decade evidence has emerged that cuffed tracheal tubes can be used as
safely as uncuffed tubes when comparing post-extubation morbidity as measured
by stridor (4-9).Official bodies such as the American Heart Association (AHA)
and the International Liaison Committee on Resuscitation (ILCOR) state in their
2005 guidelines for paediatric resuscitation, that the use of cuffed tubes in
infants and children is now an accepted alternative to uncuffed tubes (9-12).
So far, only case reports and case series of patients with tracheal intubation
injuries, mostly from oversized tracheal tubes, have been published (13, 14).
Prolonged tracheal intubation in critically ill patients can cause airway
injury (15-17). There has been no significant difference shown in clinical
symptoms such as stridor at extubation in paediatric intensive care patients
intubated with cuffed or uncuffed tracheal tubes (6). But as mentioned by some
authors, stridor at extubation is not a valid outcome measure for assessing
airway injury after prolonged tracheal intubation in children. Therefore
endoscopic evaluation of those patients is necessary(18).
To date, no large multi-centre endoscopic airway investigations have been
performed in small children with previous prolonged tracheal intubation. This
would assist in identifying risk factors for airway injury in children and help
paediatric anaesthetists and intensivists (19-21) improve the care they give to
this vulnerable group of patients. The aim of the study is to systematically
evaluate airway injury by rigid endoscopy (laryngotracheoscopy) in children
with previous prolonged (> 24h) tracheal intubation with a special focus on
whether their trachea was intubated with a cuffed or an uncuffed tracheal tube.
References
1) James I. Cuffed tubes in children. Paediatr Anaesth 2001; 11: 259-263.
2) Gerber AC, Weiss M. Pro: cuffed endotracheal tubes in small children.
Anasthesiol Intensivmed Notfallmed Schmerzther 2004; 39: 365-367
3) Holzki J. Tubes with cuffs in newborn and young children are a risk!
Anaesthesist 2002;51:321-323.
4) Khine HH, Corddry DH, Kettrick RG et al. Comparison of cuffed and uncuffed
endotracheal tubes in young children during general anesthesia. Anesthesiology
1997; 86: 627-631.
5) Dullenkopf A, Gerber AC, Weiss M. Fit and seal characteristics of a new
paediatric tracheal tube with high volume-low pressure polyurethane cuff. Acta
Anaesthesiol Scand 2005; 49:232-237.
6) Newth CJ, Rachmann B, Patel N et al. The use of cuffed versus uncuffed
endotracheal tubes in pediatric intensive care. J Pediatr 2004; 144: 333-337.
7) Weiss M, Gerber AC, Dullenkopf A. Appropriate placement of intubation depth
marks in a new cuffed paediatric tracheal tube. Br J Anaesth 2005; 94: 80-87.
8) Weiss M, Gerber AC. Cuffed tracheal tubes in children - things have changed!
Paediatr Anaesth 2006; 16: 1005-1007.
9) Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric
Endotracheal Intubation Study Group. Prospective randomized controlled
multi-centre trial of cuffed or uncuffed endotracheal tubes in small children.
Br J Anaesth. 2009; 103 :867-73.
10) American Heart Association. Part 12. Pediatric advanced life support.
Circulation 2005;112:167-187.
11) The international Liaison Committee on Resuscitation (ILCOR). Consensus
science with treatment recommendations for pediatric and neonatal patients:
pediatric basic and advanced life support. Pediatrics 2005; 117: e955-e977.
12) Golden S. Cuffed versus uncuffed endotracheal tubes in children: a review.
Newsl Am Soc Pediatr Anesth 2006; 19: 10-12.
13) Dillier CM, Trachsel D, Baulig W et al. Laryngeal damage due to an
unexpectedly large and inappropriately designed cuffed pediatric tracheal tube
in a 13-month-old child. Can J Anaesth 2004; 51: 72-75.
14) Holzki J. Laryngeal damage from tracheal intubation. Paediatr Anaesth 1997;
7: 435-437.
15) Stocks JG. Prolonged intubation and subglottic stenosis. BMJ 1966; 2:
1199-1200.
16) Codeiro AMG, Fernandes JC, Troster EJ. Possible risk factors associated
with moderate or severe airway injuries in children who underwent endotracheal
intubation. Pediatr Crit Care Med 2004; 5: 364 -368
17) Cordeiro AM, Shin SH, Fernandes Ide C, Bousso A, Troster EJ. [Incidence and
endoscopic characteristics of airway injuries associated endotracheal
intubation in children]. Article in Portuguese] Rev Assoc Med Bras 2004; 50:
87-92.
18) Holzki J, Laschat M, Puder C. Stridor is not a scientifically valid outcome
measure for assessing airway injury. Paediatr Anaesth. 2009 Jul;19 Suppl
1:180-97.
19) Goldman K, Recent developments in airway management of the paediatric
patient. Cuff Opin Anaesthesiol 2006; 19: 278-284.
20) Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, presence
and future. Expert Rev Med Devices 2006; 4: 73-82.
21) Ashtekar CS, Wardhaugh A. Do cuffed endotracheal tubes increase the risk of
airway mucosal Injury and post-extubation stridor in children? Arch Dis Child.
2005; 90: 1198-1199.
Study objective
The first objective of this study is to evaluate by direct laryngo-tracheoscopy
the possible role of cuffed versus uncuffed tracheal tubes in producing airway
injury in infants and children who were previously more than 24 hours intubated.
The second objective is to study the influence of possible risk factors of
airway injury: duration of the intubation, tube size, airway infection, shock,
sepsis, age, gender and prematurity in infants and children who were previously
more than 24 hours intubated.
Study design
In this prospective observational clinical study we will perform a rigid
laryngotracheoscopy in those children who had previous prolonged tracheal
intubation in our institution and who are now scheduled for elective surgery
with mandatory airway instrumentation. Rigid laryngotracheoscopy will be
performed by an ENT-surgeon or paediatric anaesthetists within one to five
minutes prior to final airway instrumentation in the paralysed paediatric
patient. After rigid laryngotracheoscopy, the child*s airway is secured
according to institutional guidelines (endotracheal intubation or insertion of
a laryngeal mask). All rigid laryngotracheoscopies are recorded on an
electronic storage media, available on the research endoscopy trolley. Each
record has a number corresponding with the patient*s data form. An
International Study Board Committee (assessor board) will assess the records in
a blinded manner using a systematic grading system (See attachment of the study
protocol). The study centre number will not be visible to the assessors. The
name of the person who performed the laryngotracheoscopy will not be recorded
on the study data form, but must be included in the local anaesthesia record.
Study burden and risks
In children, scheduled for elective surgical or diagnostic interventions
requiring airway instrumentation, rigid laryngo-tracheoscopy will be added to
the usual anaesthetic routine procedures. After induction of general
anaesthesia and administering of a muscle relaxant, an ENT-surgeon or
paediatric anaesthetist, trained in this procedure, will perform the endoscopy
in the preoxygenated, paralysed and conventionally monitored patient (NIBP,
ECG, and SpO2) before final airway instrumentation. The rigid endoscope with
endoscopy camera attached (outer diameter related to patient*s age) is
carefully guided through the larynx down to the carina under monitor vision
with electronically recording and then withdrawn from the patient. In case of
secretions obstructing the view to interested airway, suction with a soft or
rigid suction device is performed and rigid endoscopy repeated.
Maintenance of oxygenation has highest priority; endoscopy will be interrupted
as soon as oxygenation (SpO2) starts to decrease. After removing the rigid
endoscope from the patient face mask oxygenation is performed and the child*s
airway will be secured according to institutional guidelines. The
laryngo-tracheoscopy will last approximately 30 seconds. In this time the child
will be in apnoe. The whole procedure, including preoxygenation, positioning,
preparing the scope and camera will prolong the anesthesia with a few minutes.
During this time the child will be ventilated by the attending anesthetist.
Because the patient is paralysed before airway instrumentation the risk for
trauma by inadvertent movements is negligible. Laryngo-tracheoscopy will
prolong the anaesthetic routine procedure by a few minutes
Beside scientific information, it may be interesting for the medical team and
for the parents/patient to know, whether prior intensive care ventilation with
tracheal intubation has significantly altered the patient*s airway.
Weitemaweg 12
Rotterdam 3015 CN
NL
Weitemaweg 12
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Children, aged 1 month to 16 yrs having prior prolonged (>= 24h) tracheal intubation during ICU-stay within the study centre, who are scheduled for elective intervention such as surgery or diagnostics procedures requiring general anaesthesia with airway instrumentation involving muscle paralysis. Children for diagnosis or treatment of stridor are also included
• No known risk for regurgitation
• Written parental consent
• ASA physical status < III
Exclusion criteria
No parental written consent
• Known airway anomalies associated with syndromes or diseases such as TEF and CDH
• Known or suspected difficult intubation
• Emergency surgery or intervention
• Full stomach and/or at risk for regurgitation
• ASA physical status IV and higher
• Patients with current or prior tracheostomy
• Known, suspected or potential cervical spine pathology (e.g. Down*s Syndrome)
• Insufficient clinical details from previous prolonged intubation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37885.078.13 |