Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03369197

Enrollment

111

Registered

2017-12-11

Start date

2017-10-30

Completion date

2019-10-23

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Endoscopy, Anesthesia Morbidity

Keywords

procedural sedation, monitored anesthesia care, endoscopy

Brief summary

Detailed description

This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.

Interventions

DEVICENasal Mask

Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve

DEVICEControl: Nasal Cannula

Nasal cannula as per usual care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.

Exclusion criteria

* Left ventricular Assist Device * Severe Pulmonary Hypertension * Ejection fraction less than 35 percent * Active Congestive Heart Failure Exacerbation * Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy. * Topical lidocaine administration * Pregnancy * Previous enrollment in this study

Design outcomes

Primary

Measure	Time frame	Description
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event	Approximately 1 hour	Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.

Secondary

Measure	Time frame	Description
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring	Approximately 1 hour	Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring	Approximately 1 hour	Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation	Approximately 1 hour	Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume.
Hypoxia Duration	Approximately 1 hour	The total time in seconds of oxygen saturation below 90 percent will be recorded
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia	Approximately 1 hour	In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy	Approximately 1 hour	Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state.

Other

Measure	Time frame	Description
Short Chain Fatty Acid Concentration	Approximately 1 hour	Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide.

Countries

United States

Participant flow

Recruitment details

Patients were recruited in the Endoscopy suite at Johns Hopkins Hospital.

Participants by arm

Arm	Count
Intervention: Nasal Mask Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	53
Control: Nasal Cannula Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care	58
Total	111

Baseline characteristics

Characteristic	Intervention: Nasal Mask	Control: Nasal Cannula	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	23 Participants	16 Participants	39 Participants
Age, Categorical Between 18 and 65 years	30 Participants	42 Participants	72 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants	57 Participants	110 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) Black or African American	7 Participants	12 Participants	19 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	42 Participants	44 Participants	86 Participants
Sex: Female, Male Female	24 Participants	29 Participants	53 Participants
Sex: Female, Male Male	29 Participants	29 Participants	58 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 57
other Total, other adverse events	0 / 53	0 / 57
serious Total, serious adverse events	0 / 53	0 / 57

Outcome results

Primary

Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event

Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.