COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

The ASA classification ranges from I to III.

Patients have signed the informed consent form.

Patients scheduled to undergo sedated ERCP examination;

Disqualifiers

Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;

Severe cardiac dysfunction (<4 METs);

Severe renal insufficiency (requiring preoperative dialysis);

Child-Pugh class C;

Trial design

Design model

Single group

Treatments tested in this trial

  • The COMBO Endoscopy Oropharyngeal Airway

    Device

    Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: The COMBO Endoscopy Oropharyngeal Airway GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxia

75% ≤ SpO2 \< 90% for \<60 s

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary outcomes

1

The incidence of sub-clinical respiratory depression

90% ≤ SpO2 \< 95%

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
2

The incidence of severe hypoxia

SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other outcomes

1

The incidence of other adverse events

Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Sponsors and contacts

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