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| Name | Class |
|---|---|
| General Hospital Dubrovnik | OTHER |
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Obesity is omnipresent problem in everyday anesthesiology practice associated with low level of blood oxygen (hypoxemia) during analgo-sedation. Overweight outpatients are often scheduled for colonoscopy usually undergo analgo-sedation. In obese patients, intravenous analgo-sedation often diminish respiratory drive causing hypoxemia. To avoid hypoxemia, low-flow nasal oxygenation (LFNO) of 2-6 L/min is applied via standard nasal catheter to provide maximum 40 % of inspired fraction of oxygen (FiO2). LFNO comprises applying cold and dry oxygen which causes discomfort to nasal mucosa of patient. LFNO is often insufficient to provide satisfying oxygenation. Insufficient oxygenation adds to circulatory instability - heart rate (HR) and blood pressure (BP) disorder.
On the other side, high-flow nasal oxygenation (HFNO) brings 20 to 70 L/min of heated and humidified of O2/air mixture up to 100% FiO2 via specially designed nasal cannula. Heated and humidified O2/air mixture is much more agreeable to patient. HFNO brings noninvasive support to patients' spontaneous breathing by producing continuous positive pressure of 3-7 cmH2O in upper airways consequently enhancing oxygenation.
Investigators intend to analyze effect of HFNO vs. LFNO on oxygen saturation during procedural analgo-sedation for colonoscopy in obese adult patients.
Investigators expect that obese patients with preserved spontaneous breathing, oxygenized by HFNO vs. LFNO, will be less prone to hypoxemia thus more respiratory and circulatory stable during procedural analgo-sedation for colonoscopy.
Obese patients with applied HFNO should longer preserve: normal oxygen saturation, normal level of CO2 and O2, reflecting better respiratory stability. Investigators expect obese participnts to have more stable HR and BP, reflecting improved circulatory stability. There will be less interruption of breathing pattern of obese patients and less necessity for attending anesthesiologist to intervene.
Obese patients are often scheduled for colonoscopy under analgo-sedation. Analgo-sedation is characterized by deep conscious sedation and preserved spontaneous breathing. Continuous intravenous application of sedatives favors patients' circulatory stability and application of oxygenation contributes to maintaining adequate patients' oxygenation. Typically, low-flow nasal oxygenation (LFNO) of 2-6 L/min is applied via standard nasal catheter to provide maximum 40% of inspired fraction of oxygen (FiO2) before (preoxygenation), during (procedural oxygenation) and after (postprocedural oxygenation) until patient regains consciousness.
During analgo-sedation obese patients are prone to intervals of bradypnea and hypoventilation. Transitory apnea in obese patients could lead to hypoxemia, hypoxia, hypercapnia and hemodynamic insufficiency despite LFNO application. Fatal outcome may occur, especially at higher risk overweight patients (ASA III class). Respiratory and hemodynamic stability of morbidly obese outpatients during analgo-sedation for endoscopic procedures represent challenge to anesthesiologists. There is no generally accepted protocol of preoxygenation and intraoperative ventilatory management for obese patients. Obese (30\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight 18<BMI<30 kg/m2 LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Obese 30<BMI<40 kg/m2 LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Morbidly obese BMI ≥40 kg/m2 LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Normal weight 18<BMI<30 kg/m2 HFNO | Experimental | High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| Obese 30<BMI<40 kg/m2 HFNO | Experimental | High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| Morbidly obese BMI ≥40 kg/m2 HFNO |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-flow nasal oxygenation (HFNO) | Device | Experimental HFNO: O2 flow 40L/min, FiO2 40% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of peripheral blood oxygenation (SpO2), | Peripheral blood saturation (SpO2): Normal range ≥ 92% Acceptable deflection from normal values of peripheral blood saturation (SpO2) significant for hypoxemia is < 92%, while all values above will be considered normal. Above-mentioned parameter will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
| Change of arterial blood saturation (PaO2) | Partial pressure of oxygen (PaO2): Normal range: ≥11 kPa Partial pressure of oxygen (PaO2), ≥ 11 kPa PaO2 will be considered normal, while all values below are considered significant for hypoxemia. Above-mentioned parameter will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Change of pH (pH) | pH value of arterial blood sample : Normal values: 7.35 - 7.45. Acceptable deflection from normal values significant for acidosis: pH <7.35. Above-mentioned parameter will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita Vukovic, MD | Contact | 0989264821 | +385 | anita_vukovic1@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17579505 | Background | Becker DE, Haas DA. Management of complications during moderate and deep sedation: respiratory and cardiovascular considerations. Anesth Prog. 2007 Summer;54(2):59-68; quiz 69. doi: 10.2344/0003-3006(2007)54[59:MOCDMA]2.0.CO;2. | |
| 24634712 | Background | Anand GW, Heuss LT. Feasibility of breath monitoring in patients undergoing elective colonoscopy under propofol sedation: A single-center pilot study. World J Gastrointest Endosc. 2014 Mar 16;6(3):82-7. doi: 10.4253/wjge.v6.i3.82. |
| Label | URL |
|---|---|
| American Society of Anesthesiologists (ASA). ASA physical status classification system 2014 Oct \[internet\]. Schaumburg, Illinois, USA: ASA;2014. | View source |
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We plan to conduct prospective, parallel group, randomized controlled clinical trial.
In total, 126 participants will be included in this trial. These participants are patients scheduled for outpatient colonoscopy in analgo-sedation.
This study includes 126 patients divided in 3 groups of according to BMI: 18\
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Anesthesiologist who interviews and examines patients scheduled for colonoscopy under analgo-sedation will enroll eligible participants and will offer procedure explanation and possibility to sign uniformed written consent. Unique personal hospital admission number (UPHAN) will be assigned to all eligible participants. After that, they will be randomized to control or intervention group by using random numbers generator. Anesthesiologist who implements anesthesia will receive nontransparent envelope with assigned intervention provided by independent investigator and will not decide which participant will receive LFNO or HFNO. However, attending anesthesiologist and participants will unavoidably be aware of type of oxygenation applied. Investigator who collects data after procedure will be unaware of study protocol and will enter data to formatted database. Participants' data will be noted under UPHAN. Outcome assessors will be unaware of intervention applied.
High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| low-flow nasal oxygenation (LFNO) | Device | Active comparator (LFNO): O2 flow 5L/min, FiO2 40% |
|
| Change of partial pressure of CO2 (PaCO2) | Partial pressure of CO2 (PaCO2): Normal range: 4.7 - 6.4 kPa. Acceptable deflection from normal values significant for hypercapnia: PaCO2 ≥ 6 kPa Above-mentioned parameter will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
| Change of normopnea (FoB) | Frequency of breathing. (FoB/min - number of breaths per minute). Normal range: 12 - 20 breaths per minute. Bradypnoea will be noted when number of breaths is less than 12 breaths/min. | From the beginning of oxygenation and analgo-sedation till the end of analgo-sedation and oxygenation - complete procedure duration estimated: 35 minutes |
| Change of frequency of desaturation (fDE) | Frequency of desaturation during time of analgo-sedation: (fDE/min, SpO2<92%). Normal range: fDE ≤1/30, up to one episode of desaturation from the start to the end of analgo-sedation. Acceptable deflection from normal range: more than one desaturation in 30 minutes. | From the beginning of oxygenation and analgo-sedation till the end of analgo-sedation and oxygenation - complete procedure duration estimated: 35 minutes |
| Change of duration of desaturation (DE/min) | Duration of desaturation (DE/min). Normal range: up to one minute. Duration of desaturation longer then one minute will be considered as insufficient ventilation. | From the beginning of oxygenation and analgo-sedation till the end of analgo-sedation and oxygenation - complete procedure duration estimated: 35 minutes |
| Change of frequency of bradypnoea during analgo-sedation (fBRP/min) | Frequency of bradypnoea during analgo-sedation (fBRP/min), Normal range: fBRP ≤1/30, up to one episode of bradypnoea from the start to the end of analgo-sedation. Acceptable deflection from normal range: > one episode of bradypnoea during 30 minutes. | From the beginning of oxygenation and analgo-sedation till the end of analgo-sedation and oxygenation - complete procedure duration estimated: 35 minutes |
| Change of heart rate (HR/min) | Heart rate (HR/min): normal range 60 -100/min. Acceptable deflection from normal values is < 60 heartbeats/min significant for bradycardia, while all values up to 100 heartbeats per minute will be considered normal. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
| Change of mean arterial pressure (MAP) | Mean arterial pressure (MAP): normal range: 65 -110 mmHg Acceptable deflection from normal values is < 65 mmHg - significant for hypotension. | Before procedure: 1 minute before start of analgo-sedation and oxygenation, During procedure: 15 minutes from beginning of oxygenation and analgo-sedation, After procedure: 5 minutes after discontinuing oxygenation and analgo-sedation |
| 29719796 | Background | Lee CC, Perez O, Farooqi FI, Akella T, Shaharyar S, Elizee M. Use of high-flow nasal cannula in obese patients receiving colonoscopy under intravenous propofol sedation: A case series. Respir Med Case Rep. 2018 Feb 3;23:118-121. doi: 10.1016/j.rmcr.2018.01.009. eCollection 2018. |
| 23740356 | Background | Frieling T, Heise J, Kreysel C, Kuhlen R, Schepke M. Sedation-associated complications in endoscopy--prospective multicentre survey of 191142 patients. Z Gastroenterol. 2013 Jun;51(6):568-72. doi: 10.1055/s-0032-1330441. Epub 2013 Jun 5. |
| 24182650 | Background | Frat JP, Goudet V, Girault C. [High flow, humidified-reheated oxygen therapy: a new oxygenation technique for adults]. Rev Mal Respir. 2013 Oct;30(8):627-43. doi: 10.1016/j.rmr.2013.04.016. Epub 2013 May 29. French. |
| 26106206 | Background | Nagata K, Morimoto T, Fujimoto D, Otoshi T, Nakagawa A, Otsuka K, Seo R, Atsumi T, Tomii K. Efficacy of High-Flow Nasal Cannula Therapy in Acute Hypoxemic Respiratory Failure: Decreased Use of Mechanical Ventilation. Respir Care. 2015 Oct;60(10):1390-6. doi: 10.4187/respcare.04026. Epub 2015 Jun 23. |
| 28089816 | Background | Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13. |
| 23657182 | Background | Nathanson V. Revising the Declaration of Helsinki. BMJ. 2013 May 8;346:f2837. doi: 10.1136/bmj.f2837. No abstract available. |
| 20410783 | Background | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available. |
| 17931878 | Background | Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10. |
| 23845744 | Background | Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and active humidification in adults. Rev Port Pneumol. 2013 Sep-Oct;19(5):217-27. doi: 10.1016/j.rppneu.2013.03.005. Epub 2013 Jul 8. |
| 27372775 | Background | Jirapinyo P, Thompson CC. Sedation Challenges: Obesity and Sleep Apnea. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):527-37. doi: 10.1016/j.giec.2016.03.001. |
| 30227319 | Background | Bignami E, Saglietti F, Girombelli A, Briolini A, Bove T, Vetrugno L. Preoxygenation during induction of anesthesia in non-critically ill patients: A systematic review. J Clin Anesth. 2019 Feb;52:85-90. doi: 10.1016/j.jclinane.2018.09.008. Epub 2018 Sep 15. |
| 26545146 | Background | Shah U, Wong J, Wong DT, Chung F. Preoxygenation and intraoperative ventilation strategies in obese patients: a comprehensive review. Curr Opin Anaesthesiol. 2016 Feb;29(1):109-18. doi: 10.1097/ACO.0000000000000267. |
| Programiz \[internet\].Kupandole, Nepal: Parewa Labs Pvt. Ltd. \[cited 2018 Sept17\]. Flowchart in programming. Available from: | View source |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D009765 | Obesity |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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