Christian Rouphael
Beirut, Lebanon
NCT Number: NCT04123821
The goal of this prospective, multi-center, single-blinded randomized controlled trial is to assess the efficacy of NPA in reducing respiratory events in patients being admitted for GI endoscopy (colonoscopy, gastroscopy, endoscopic ultrasound) under deep sedation. The main question it aims to answer are: • [Is the NPA used on patients undergoing gastrointestinal endoscopy efficient in reducing respiratory events?] Participants will be randomly allocated into one of the two groups: NPA with 5L/min oxygen through nasal cannula (group A) or 5 L/min oxygen through nasal cannula alone (group B). Researchers will compare NPA group to nasal cannula group to see if the routine placement of an NPA can reduce the frequency of airway obstruction, hypoxemic events and airway maneuvers (chin lift, oral airway insertion, and mask-bag ventilation) during endoscopic sedation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Beirut, Lebanon
Monitored anesthesia care (MAC) is currently the dominant method of endoscopic sedation for approximately one third of all US gastroenterologists. The popularity and success of MAC can be ascribed to many factors including increased patient turnover and improved patient satisfaction. Patients undergoing MAC maintain spontaneous breathing and routinely receive supplemental oxygen. In case of airway obstruction, additional airway adjuncts may be used such as supraglottic airway devices including oropharyngeal airway, nasopharyngeal airway, laryngeal mask, etc. A nasopharyngeal airway (NPA) is a simple device that can be conveniently inserted into the supraglottic airway to secure an open passage. This is a prospective, multi-center, single-blinded randomized controlled trial designed to evaluate the efficacy of the routine use of NPA in preventing airway obstruction during deep sedation. Patients undergoing gastrointestinal endoscopy under monitored anesthesia care using target-controlled infusion of propofol at AUBMC will be randomly and equally apportioned to the NPA (group A) or nasal cannula group (group B). Episodes of desaturation, airway maneuvers, hemodynamic instability, adverse events related to NPA insertion, duration of the procedure, and the anesthetic dose will be recorded. The satisfaction of the anesthesiologist, gastroenterologist, and patient will be scored. The aim of this study is first to assess the efficacy of NPA in reducing respiratory events, and second, to identify the safety of this device as well as patient, gastroenterologist and anesthesiologist satisfaction.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A disposable nasopharyngeal airway of appropriate size will be selected for patients allocated to the intervention group with 5L/min oxygen through nasal cannula
Time frame: During the procedure
oxygen saturation (%)
Time frame: During the procedure
Occurrence of the event (chin lift/jaw thrust):yes or no and the number of episodes if yes
Time frame: During the procedure
Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes
Time frame: During the procedure
Occurrence of the event (intubation): yes or no and the number of episodes if yes
Time frame: During the procedure
Occurrence of the event (Interruptions during the case): yes or no and the number of episodes if yes
Time frame: During the procedure
Occurrence of the event (SBP<90 mmHg): yes or no and the number of episodes if yes
Time frame: During the procedure
Occurrence of the event (HR<50 beats/min): yes or no and the number of episodes if yes
Time frame: During the procedure
Development of epistaxis: yes or no and the number of episodes if yes
Time frame: During the procedure
Development of cough: yes or no and the number of episodes if yes
Time frame: During the procedure
Development of laryngospasm: yes or no and the number of episodes if yes
Time frame: During the procedure
Patient's movement impeded the procedure :yes or no and the number of episodes if yes
Time frame: Up to 2 hours after the procedure
Satisfaction score of the anesthesiologist on a numerical rating scale from 0 to 10
Time frame: Up to 2 hours after the procedure
Satisfaction score of the proceduralist on a numerical rating scale from 0 to 10
Time frame: Up to 2 hours after the procedure
Satisfaction score of the patient on a numerical rating scale from 0 to 10
Time frame: During the procedure
Duration of the procedure in minutes
Time frame: During the procedure
Total amount of Propofol in mg
American University of Beirut Medical Center
Other
The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy: A Multi-center Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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