Improve Oxygenation and Capnographic Detection During Sedative EGD

Apnea, Obstructive Clinical Trial

Official title:

Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138850
• Other study ID #: 2017-03-003B
• Status: Completed
• Phase: N/A
• First received: April 18, 2017
• Last updated: July 6, 2017
• Start date: May 3, 2017
• Est. completion date: June 22, 2017

Study information

• Verified date: May 2017
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of mandibular advancement bite block and high flow nasal cannula to standard bite block for oxygenation, capnographic measurement, prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.

Description:

During endoscopic examinations, especially during those performed via oral insertion of endoscopes, an oral bite is used to protect the examination instruments and patients. During sedated endoscopic examinations, the patients are under influence of anesthetics. Upper airway obstruction often occurred due to respiratory depression and airway collapse resulting in desaturation. Airway management with high percentage oxygen, jaw thrust, or insertion of nasal airways by trained anesthetic personnel is required during upper airway obstruction emergencies. Nasal airway is invasive and causes nasal bleeding, sinusitis and other problems. Jaw thrust and bag-mask ventilation requires training and is a burden to anesthetic personnel to perform. Oxygenation and capnography are important ventilatory monitors during sedative procedures. These are often influenced by open mouth breathing during upper gastrointestinal endoscopic examinations making oxygenation and capnographic measurements unreliable. In this study, we group the patients into A group using standard of care, B group using mandibular advancement oral bite and C group using high-flow nasal cannulas. After anesthetic induction, gastric endoscopy will be performed. Oxygenation, end-tidal carbon dioxide, and degree of upper airway obstruction will be evaluated and recorded. Differences between the groups will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy

Exclusion Criteria:

• Baseline oxygen saturation < 90%

• Known upper airway obstruction, difficult intubation history

• Unstable or lost of upper and lower incisors

• Known past oral or neck surgeries

• Anticipate exam time > 30 mins

Related Conditions & MeSH terms

• Airway Obstruction
• Apnea, Obstructive
• Sleep Apnea, Obstructive
• Upper Airway Obstruction

Intervention

Device:
• Olympus standard bite block
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min
• YX mandibular advancement bite block
Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min
• Optiflow High flow nasal cannula
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of 95% oxygen desaturation (AUCdesat)	AUCdesat is defined as the integrated area under oxygen saturation (SPO2) for a selected cut point per 30 seconds, which better reflects the duration and severity of hypoxemia than the lowest saturation	From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary	Number of rescue interventions	Number of rescue interventions counted if any of the following procedures are performed, such as sustained chin lift or jaw thrust, insertion of an oral or nasal airway or bag-mask ventilation.	From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary	Number of apnea episodes	Number of apnea episodes, which are number of times which the patient lack respiratory activity and loss of ETCO2 detection greater for 30 seconds occurs.	From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary	Number of partial airway obstruction episodes	Number of partial airway obstruction episodes, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.	From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary	Number of total airway obstruction episodes	Number of total airway obstruction episodes, which are number of times loss of ETCO2 detection while in presence of respiratory activity greater than 30 secs occurs.	From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour