Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation

Intubation Clinical Trial

Official title:

Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350933
• Other study ID #: Endostudy
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes.

Description:

The aim of the study is to systematically evaluate airway injury by rigid endoscopy in children (1 month to 16 years of age) with previous prolonged (> 24h) tracheal intubation with a special focus on whether their trachea was intubated with a cuffed or an uncuffed tracheal tube.

After induction of anaesthesia and obtaining venous access, neuromuscular blocking agents are administered and facemask pre-oxygenation occurs for 2 minutes. Direct laryngoscopy is then performed in the preoxygenated, paralysed and conventionally monitored patient to obtain a direct vision. Then a rigid endoscope with endoscopy camera is carefully guided through the larynx down to the carina and drawn back under monitor vision with electronic recording.

An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.

Beside tracheal tube type, factors such as intubator, sedation management, age, length of intubation, nasal or oral intubation and time point of endoscopy will affect presence, absence or incidence of potential airway injuries caused by prolonged tracheal intubation. Thus it is difficult to perform a power calculation to figure out number of patients to demonstrate or exclude a statistically significant difference between tube types. Using the incidence of subglottic stenosis, as the worst case scenario outcome after longterm intubation, an incidence of less than 2 % seems to be reasonable in uncuffed tracheal tubes.So the primary hypothesis to be tested is equivalence in major complication rates defined as subglottic stenosis comparing cuffed versus uncuffed tracheal tubes.

Specifically, the primary hypothesis relates to the main outcome criteria of this study, which is subglottic stenosis after longterm intubation. The null-hypothesis Ho is defined as no difference in the incidence rates of subglottic stenosis between cuffed and uncuffed groups. The null-hypothesis (Ho: μ-Diff = 0) will be compared with the alternative hypothesis (H1: μ-Diff <> 0). The study is designed to detect a clinically unacceptable deterioration of 4% above the baseline airway-injury rate of 2% when using uncuffed tubes with a power of 80% and a type I error probability of less than 5%. Sample sizes of 376 from the cuffed group and 376 from the uncuffed group achieve 80% power at a 5% significance level using a one-sided equivalence test of proportions when the proportion in the standard group (uncuffed TT) is 0.02 and the proportion in the experimental group (cuffed TT) being tested for equivalence is 0.02 and the maximum allowable increase between these proportions that still results in equivalence (the range of equivalence) is 0.04. In total 1000 patients with prior long-term intubation (> 24 hours) using a cuffed (500) or an uncuffed (500) tracheal tube will be recruited / included from different study centres.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Planned elective intervention/surgery/diagnostics/endoscopy and general anaesthesia with airway instrumentation involving muscle paralysis in children, aged 1 month (UK) or from birth (other centers) to 16 years having prior prolonged (= 24h) tracheal intubation (s) during ICU-stay (s) within the study centre (patients for diagnosis/treatment of stridor are also included (see exclusion criteria also below)).

• No known risk for regurgitation

• Written parental consent

• American Society of Anesthesiologists (ASA) physical status < IV

Exclusion Criteria:

• No parental written consent

• Known airway anomalies associated with syndromes

• 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

Related Conditions & MeSH terms

• Endoscopy
• Intubation

Intervention

Procedure:
• Endoscopy
A rigid endoscopy of the larynx and the trachea until the carina is performed using a rigid 0° endoscope.

Locations

Country	Name	City	State
Germany	Kinderkrankenhaus Amsterdamer Straße	Köln	Nordrhein-Westfalen
Germany	Asklepios Kinderklinik Sankt Augustin	Sankt Augustin	Nordrhein-Westfalen
Netherlands	Erasmus Medical Center, Sophia Children's Hospital	Rotterdam
Switzerland	University Children's Hospital	Zurich
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (5)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	Asklepios-Klinik Sankt Augustin, Erasmus Medical Center, Great Ormond Street Hospital for Children NHS Foundation Trust, Kinderkrankenhaus Amsterdamer Straße

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes	An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.	After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy
Secondary	Numbers of prior intubations	Numbers of shortterm and prolonged (>24h) and numbers of intubations with cuffed and uncuffed tubes are listed	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Duration of prior longterm intubation		Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Reason for prior longterm intubation	Reason for prior longterm intubation is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Route of prior longterm intubation	Route of prior longterm intubation (nasal or oral) is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Tube type used for prior longterm intubation	Tube type used for prior longterm intubation (cuffed or uncuffed) is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Tube brand used for prior longterm intubation	Tube brand used for prior longterm intubation is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Tube size used for prior longterm intubation	Tube size (inner diameter) used for prior longterm intubation is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Site of prior longterm intubation	Site of prior longterm intubation is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Maximal cuff pressure during prior longterm intubation	Maximal cuff pressure in cmH2O during longterm intubation is look up in patient's medical records.	Retrospective data analysis of former intubations is performed within two years after the endoscopy
Secondary	Number of patients with a stridor event after extubation of prior longterm intubation		Retrospective data analysis of former intubations is performed within two years after the endoscopy