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Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

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ClinicalTrials.gov Identifier: NCT03529461
Recruitment Status : Completed
First Posted : May 18, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Makram Gedeon, MD, Bristol Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Severe Obesity
Hypoxia
Interventions Device: Non-invasive positive pressure ventilation through nasal mask
Device: Rescue non-invasive positive pressure ventilation through nasal mask
Other: Secondary rescue maneuvers
Enrollment 56
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)
Arm/Group Title Control Experimental
Hide Arm/Group Description

Intervention: nasal cannula 6L O2 + non invasive positive pressure (NIPPV) nasal mask not connected to machine

Rescue NIPPV via nasal mask: If oxygen 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 saturation 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 oxygen saturation > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist

Intervention: NIPP placed on patient. Positive pressure applied 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 NIPPV maneuver attempted (including adjustments in pressure) and O2 saturation is not above 90 % within 3 min of starting NIPPV, endoscope 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 saturation > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase > 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist

Period Title: Overall Study
Started 28 28
Completed 28 28
Not Completed 0 0
Arm/Group Title Control Experimental Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
38.8  (11.6) 36.5  (11.8) 37.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
25
  89.3%
23
  82.1%
48
  85.7%
Male
3
  10.7%
5
  17.9%
8
  14.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Hispanic or Latino
8
  28.6%
10
  35.7%
18
  32.1%
Not Hispanic or Latino
20
  71.4%
18
  64.3%
38
  67.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 56 participants
28 28 56
1.Primary Outcome
Title Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: percentage of participants
57.1 14.3
2.Primary Outcome
Title Percentage of Participants With an Oxygen Desaturation Event < 90%
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: percentage of participants
28.6 3.5
3.Secondary Outcome
Title Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
Hide Description 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 %
Hide Outcome Measure Data
Hide Analysis Population Description
We report on the response of 8 participants in the control group who had an oxygen desaturation event less than 90 %
Arm/Group Title Control Participants With Oxygen Desaturation < 90%
Hide Arm/Group Description:
Rescue NIPPV: 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. 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
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
Time Frame 1800 seconds (30 minutes)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Experimental
Hide Arm/Group Description

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

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

All-Cause Mortality
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Makram Gedeon, MD
Organization: Bristol Hospital
Phone: 8605853339
EMail: mgedeon@bristolhospital.org
Publications:
Layout table for additonal information
Responsible Party: Makram Gedeon, MD, Bristol Hospital
ClinicalTrials.gov Identifier: NCT03529461     History of Changes
Other Study ID Numbers: 20170730
First Submitted: May 3, 2018
First Posted: May 18, 2018
Results First Submitted: March 27, 2019
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019