The Effect of Nasal Continuous Positive Airway Pressure on Oxygenation in High-risk Patients Having Gastrointestinal Endoscopy Under Deep Sedation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Incidence of hypoxemia
Study Overview
Brief Summary
Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Nasal continuous positive airway pressure may help to decrease the incidence of peri-interventional hypoxemia. However, data on nasal continuous positive airway pressure in high-risk patients having gastrointestinal endoscopy are scarce; only one randomized trial on gastroscopy in obese patients is available (Kang et al. J Anesth 2021). In a very high-risk group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).
Aim of this trial is the effect of nasal continuous positive airway pressure - compared to nasal oxygen insufflation - on the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
The investigators hypothesize that nasal continuous positive airway pressure - compared to nasal oxygen insufflation - reduces the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
Detailed Description
High risk patients were defined as American Society of Anaesthesiology (ASA) class >3 and/or BMI ≥30 kg/m², in accordance with the current World Health Organization (WHO) definition of obesity scheduled for elective gastrointestinal endoscopy with deep sedation.
The main objective was investigating the incidences of hypoxemia defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (company: Masimo; type: Root) after inducing deep sedation while under endoscopy intervention. Secondary outcomes such as the duration of the whole intervention, the duration of hypoxemia or the incidence of need for airway interventions will also be investigated.
Patients will be randomized and divided into nCPAP group and nasal oxygenation insufflation group.
Depending on the type of endoscopy a positive airway pressure between 3 and 10 cmH20 can be generated with the nCPAP mask using an oxygenflow rate of 6l/min.
Deep sedation will be performed under surveillance of an anaesthesia team using only propofol bolus adjusted to predicted body weight (PBW)(1mg/kg) followed by continuous infusion of 4mg/kg/h adjusted to lean body weight (LBW), which is described by MacDonald et al. (doi: 10.1177/1751143714565059) as :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult and obese high-risk patients (ASA class ≥3 and/or BMI ≥30 kg/m², in accordance with the current WHO definition of obesity) scheduled for elective gastrointestinal endoscopy with deep sedation.
Exclusion Criteria
- •Age < 18 years
- •Pregnancy
- •Cognitive impairment, that makes consent to study impossible
- •Known but untreated heart disease (e.g. persistent foramen ovale (PFO), recent congestive heart failure), complicating comparability within groups
Arms & Interventions
nasal continuous positive airway pressure
nasal continuous positive airway pressure (3-10cmH20) administered with 6 l/O2 with the SuperNO2VA™ Et produced by Vyaire Medical, Inc.
Intervention: SuperNO2VA™ Et by Vyaire Medical, Inc. (Device)
nasal oxygen insufflation
nasal oxygen insufflation with 6 l/02 will be administered as control-group/standard intervention for endoscopy
Intervention: nasal oxygen cannula (Device)
Outcomes
Primary Outcomes
Incidence of hypoxemia
Time Frame: Time between Induction of deep sedation and end of procedure (endoscopy)
hypoxemia is defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (Phillips IntelliVue and Massimo Rad-97) after inducing deep sedation while under endoscopy intervention.
Secondary Outcomes
- Endtidal CO2 (carbon dioxide)(Time between Induction of deep sedation and end of procedure (endoscopy))
- Duration of hypoxemia(Time between Induction of deep sedation and end of procedure (endoscopy))
- Hypoxemic events(Time between Induction of deep sedation and end of procedure (endoscopy))
- hypoxemia duration to procedure duration(Time between Induction of deep sedation and end of procedure (endoscopy))
- Airway intervention(Time between Induction of deep sedation and end of procedure (endoscopy))
- Duration of intervention(Time between Induction of deep sedation and end of procedure (endoscopy))
- Sedation score(Time between Induction of deep sedation and end of procedure (endoscopy))