Hypoxia, Severe Obesity
Conditions
Keywords
severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, BMI, anesthesia, complications
Brief summary
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.
Detailed description
Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 \<=94%) and desaturation events requiring intervention (SpO2\<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.
Interventions
DEVICENon-invasive positive pressure ventilation through nasal mask
Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
DEVICERescue non-invasive positive pressure ventilation through nasal mask
If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
OTHERSecondary rescue maneuvers
If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \> 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
Sponsors
Bristol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Weight loss surgery patients undergoing preoperative upper endoscopy * BMI 40-60
Exclusion criteria
* Pregnant patients * Previous weight loss surgery or stomach surgery * BMI \> 60 and BMI \< 40 * Active smokers * Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks * Lung disease, COPD asthma, cystic fibrosis, sarcoidosis * Baseline O2 saturation less than or equal to 94% * Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Oxygen Desaturation Event ≤ 94% | Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli). | Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94% |
| Percentage of Participants With an Oxygen Desaturation Event < 90% | Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli). | Percentage of participants who develop a peripheral oxygen saturation event \< 90%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV | 3 minutes following a desaturation event < 90 % | We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on 4/25/2017 and ended on 4/2/2018.
Pre-assignment details
208 patients assessed for eligibility: * 56 patients enrolled * 152 patients excluded (reasons: 127 not meeting inclusion criteria or no show for procedure, 6 patients declined to participate, 19 patients excluded because of early trial closure)
Participants by arm
| Arm | Count |
|---|---|
| Control Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine
Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist | 28 |
| Experimental Intervention: Non invasive positive pressure nasal mask connected once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 11.6 | 36.5 years STANDARD_DEVIATION 11.8 | 37.6 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 18 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Percentage of Participants With an Oxygen Desaturation Event < 90%
Percentage of participants who develop a peripheral oxygen saturation event \< 90%.
Time frame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Participants With an Oxygen Desaturation Event < 90% | 28.6 percentage of participants |
| Experimental | Percentage of Participants With an Oxygen Desaturation Event < 90% | 3.5 percentage of participants |
Primary
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Time frame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Participants With an Oxygen Desaturation Event ≤ 94% | 57.1 percentage of participants |
| Experimental | Percentage of Participants With an Oxygen Desaturation Event ≤ 94% | 14.3 percentage of participants |
Secondary
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.
Time frame: 3 minutes following a desaturation event < 90 %
Population: We report on the response of 8 participants in the control group who had an oxygen desaturation event less than 90 %
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV | 8 Participants |