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

NCT ID: NCT02350933

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Intubation; Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

0° rigid endoscope

Endoscopy of the trachea is performed using a 0° rigid endoscope

Group Type: OTHER

Endoscopy

Intervention Type: PROCEDURE

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

Interventions

Endoscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• No known risk for regurgitation
• Written parental consent
• American Society of Anesthesiologists (ASA) physical status < IV

• 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

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Asklepios-Klinik Sankt Augustin

OTHER

Sponsor Role: collaborator

Kinderkrankenhaus Amsterdamer Straße

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Weiss, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

Kinderkrankenhaus Amsterdamer Straße

Cologne, North Rhine-Westphalia, Germany

Asklepios Kinderklinik Sankt Augustin

Sankt Augustin, North Rhine-Westphalia, Germany

Erasmus Medical Center, Sophia Children's Hospital

Rotterdam, , Netherlands

University Children's Hospital

Zurich, , Switzerland

Great Ormond Street Hospital for Children NHS Foundation Trust

London, , United Kingdom

Countries

Germany; Netherlands; Switzerland; United Kingdom

Other Identifiers

Endostudy

Identifier Type: -

Identifier Source: org_study_id