Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center

Not Applicable

Withdrawn

• Conditions: Positive-Pressure Respiration; Colonoscopy
• Interventions: Device: Nasal Positive Airway Pressure System; Device: Nasal Cannula

• Registration Number: NCT05754255
• Lead Sponsor: Indiana University

Brief Summary

The primary objective of the prospective study is to compare the incidence, duration, and severity of oxygen desaturation in high-risk patients randomized to nasal mask with nasal positive airway pressure (PAP) or standard care (nasal cannula) receiving propofol sedation during colonoscopy in an ambulatory surgical center (ASC).

Patients will be randomized in groups of ten to one of two groups using a random number table.

Group A: standard care with a nasal cannula. Group B: SuperNO2VA™EtCO2. Following the procedure subjects will be asked to complete satisfaction surveys before leaving the ASC and 48 +/- hours following their procedure.

Researchers will compare levels of satisfaction and levels of oxygen saturation.

Detailed Description

This study involves the oxygenation, continuous positive airway pressure, and ventilation of a subject via nasal mask and oxygenation via a closed facemask. The interventions directly related to this study are that of supplement oxygen, bag-mask ventilation, and continuous nasal CPAP intra-operatively and in the recovery unit.

Patients will be randomized in groups of ten to one of two groups using a random number table.

Group A: standard care with a nasal cannula. Group B: SuperNO2VA™EtCO2. For each anesthetic case, a preoperative history and physical and intraoperative record will be documented.

Once in the endoscopy suite, the patients will have baseline vital signs, EtCO2 and oxygen levels measured. Continuous monitoring of heart rate, end tidal CO2 (EtC02), O2 saturation, and every 3-minutes BP monitoring will be obtained. For patients randomized to group A, the anesthesia provider will supply oxygen via nasal cannula at 10LPM. For patients randomized to group B, the anesthesia provider will attach the SuperNO2VA™ EtCO2's circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min, and the adjustable pressure-limiting (APL) valve completely closed. Initial propofol bolus of 0.5-1.0 mg/kg actual body weight will be administered for sedation. No other sedative or analgesic will be permitted besides propofol. MOAA/S scores will be assessed by the anesthesiologist and medical team and recorded by the research assistant. If the patient's MOAA/S score is ≥ 4, additional 20-50 mg boluses will be administered every 30 - 90 seconds until a MOAA/S score \<4 is reached. Once a MOAA/S \<4 is reached the endoscopist will insert the colonoscope into the rectum. Sedation will be titrated to maintain a MOAA/S \<4 throughout the procedure. If the patient's MOAA/S score ≥4, additional 20-50 mg boluses of propofol will be administered every 30-90 seconds until the MOAA/S is \<4. The measurements recorded during colonoscopy for both groups will be: time of administration of sedation; incidence, severity, and duration of oxygen desaturation; number, duration and reason for performing the airway maneuver(s); duration of the procedure; total dose of medication; blood pressure, heart and respiratory rate, and oxygen saturation; time to full recovery; and patient cooperation. The research assistant will document their patient's depth of sedation, cooperation with procedure, and safety.

Endoscope techniques performed during the procedure such as biopsies, dilation, polypectomy, etc. will be tracked. Techniques to facilitate proximal passage of the endoscope such as moving the patient or abdominal pressure will also be noted. If the anatomic extent desired to complete the colonoscopy is not reached (i.e., colon stricture, excessive looping of the instrument), then the patient will be withdrawn from the study.

Patients will recover in the endoscopy suite. The patients will have continuous monitoring of heart rate, end tidal CO2 (EtC02), O2 saturation, and every 5-minute BP monitoring and MOAAS Score. Once a MOAAS score of 5 is obtained, the patient will be offered to drink independently unless deemed inappropriate by the treating physician(s). The endoscopist when available will discuss findings with the patient and/or family, the patient will then dress and leave the endoscopy suite when possible. The time to discharge will be obtained for each patient. Patients will also complete a satisfaction and pain questionnaire before discharge. Subjects will be sent surveys to complete at 48 hours post discharge, concerning their satisfaction and their subjective degree of impairment due to the sedation. They will have the option to complete this electronically via a link to REDCap or with a self-addressed envelope and paper form of the survey. If the patients do not complete or send back their questionnaire, someone will contact them by telephone to collect the data. A statistician using student T-test, Fishers exact test, and other statistical methods they deem appropriate will analyze the collected data.

Study Timeline

• Study First Submitted: 2022-12-31
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Study Start: 2023-09
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥18 years
2. Outpatients undergoing colonoscopy.
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. BMI ≥35 kg/m2, documented obstructive sleep apnea or BMI>30 with STOP-BANG score ≥3
5. Written informed consent

Exclusion Criteria

1. Inpatient status
2. Active Congestive Heart Failure Exacerbation
3. Untreated ischemic heart disease
4. Acute exacerbation of respiratory disorders, including COPD and asthma
5. Emergent procedures
6. Pregnancy
7. Previous enrollment in this study
8. Inability to provide informed consent.
9. Additional medical testing planned for the same day.
10. History of allergic reaction to propofol
11. History of allergic reaction to polypropylene or PVC.
12. Tracheostomy
13. Supra-glottic or sub-glottic tumor
14. Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
15. Known obstructing colon tumor, lesion, or stricture
16. Previous colon surgery (excluding anal surgery)
17. Active GI bleeding (hematochezia or melena during procedure preparation)
18. Large polyp (> 2cm) removal
19. Previous failed or unsuccessfully completed colonoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: SuperNO2VA™EtCO2	Nasal Positive Airway Pressure System	Group B will be given a nasal oxygen to deliver gas, create a seal, and provide positive pressure. The mask will be placed over a patient's nose and connected to either an anesthesia circuit or hyperinflation bag during respiratory, anesthesia, and resuscitation procedures.
Group A: standard care with a nasal cannula.	Nasal Cannula	Group A will be given the standard nasal cannula during sedation. The cannula prongs will be inserted into the patient's nose to provide oxygen to the patient.

Primary Outcome Measures

Name	Time	Method
Severity of oxygen desaturation	60 minutes	Compare the severity of desaturation of Nasal PAP Versus Nasal Administration of Oxygen
Incidence of desaturation	60 minutes	Compare incidence of desaturation of Nasal PAP Versus Nasal Administration of Oxygen
Duration of oxygen desaturation	60 minutes	Compare the duration of desaturation of Nasal PAP Versus Nasal Administration of Oxygen

Secondary Outcome Measures

Name	Time	Method
Endoscope Insertion	60 minutes	Compare the length of time from induction to endoscope insertion.
Duration of Airway maneuvers	60 minutes	Compare the duration for airway maneuvers
Use of endotracheal intubation	60 minutes	Compare the use of endotracheal intubation as airway management in patient population.
Incidence of Airway maneuvers	60 minutes	Compare the number of incidence of airway maneuvers
Reason(s) for airway maneuvers	60 minutes	Compare reason(s) for airway maneuvers as reported by anesthesiologist via open ended interview in real time.
Frequency of low respiratory rate	60 minutes	Compare the frequency of low respiratory rate (\<6 per minute between the start and end of sedation.
Total Amount of Propofol for Adequate Sedation	60 minutes	Compares amounts of Propofol for induction and entire procedure administered for procedure
Modified Observer's Assessment of Alertness/Sedation Scale	60 minutes	Compare Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) scores immediately prior to endoscope insertion and during the procedure.; MOAAS scale is 0-5, where 0=No response after painful stimuli and 5 Responds to name spoken in normal tone. Patients with a MOAAS \<4 are considered to be moderately to deeply sedated. The greater the degree of sedation the greater the degree of respiratory depression.
Incidence of any desaturation	60 Minutes	Compare the incidence of any oxygen desaturation \<85% between the start and end of sedation.
Frequency of Procedural Interruption	60 minutes	Compare the frequency of the removal of endoscope due to a respiratory complication from start to end of sedation.
Patient Satisfaction	48 hours	Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure.; VAS range is from 0= Not at all satisfied to 5=Completely satisfied.
Use of Noninvasive positive pressure ventilation	60 minutes.	Compare the use of noninvasive positive pressure ventilation as airway management in patient population during sedation.
Incidence of hospitilization	48 hours	Compare the incidence of hospitalization following sedation for a colonoscopy in patient population.
Frequency of Oxygen Saturation	60 minutes	Compare the frequency of oxygen saturation saturation \<85% over 15 seconds between the start and end of sedation.
Frequency of bradycardia	60 minutes	Compare the frequency of bradycardia (HR\<45 bpm)between the start and end of sedation.
Use of pharmacological blood pressure support	60 minutes.	Compare the use of pharmacological blood pressure support from the start and end of sedation.
Serious Adverse Events	48 hours	Compare incidence of adverse events from start of sedation to 48 hours following the end of sedation.
Duration of Procedural Interruption	60 minutes.	Compare the duration of endoscope removal due to a respiratory complication from start of sedation to end of sedation.
Length of Procedure	60 minutes	Compare the length of time for procedure from start of sedation to end of sedation.
Ready to discharge	30 min	Compare the length of time from end of sedation to ready to discharge
Time to discharge	90 minutes	Compare the length of time from end of sedation to actual discharge.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States