Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?

NCT03687424 | Unknown

• 1 other identifier: 01-285/8-3-17-B
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Noninvasive Ventilation; Respiratory Insufficiency; Obesity; Deep Sedation; Hypoxia; Airway Management; Colonoscopy

Keywords

"Noninvasive Ventilation"[Mesh]; "Obesity"[Mesh]; "Deep Sedation"[Mesh]; "Hypoxia"[Mesh]; "Adult"[Mesh]; "Airway management"[Mesh]; "Colonoscopy"[Mesh]

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Change of pH (pH)

  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 partial pressure of CO2 (PaCO2)

  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)

  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)

  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)

  From the beginning of oxygenation and analgo-sedation till the end of analgo-sedation and oxygenation - complete procedure duration estimated: 35 minutes

Study Arms (6)

Normal weight 18<BMI<30 kg/m2 LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: low-flow nasal oxygenation (LFNO)

Obese 30<BMI<40 kg/m2 LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: low-flow nasal oxygenation (LFNO)

Morbidly obese BMI ≥40 kg/m2 LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: low-flow nasal oxygenation (LFNO)

Normal weight 18<BMI<30 kg/m2 HFNO

EXPERIMENTAL

High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: high-flow nasal oxygenation (HFNO)

Obese 30<BMI<40 kg/m2 HFNO

EXPERIMENTAL

High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: high-flow nasal oxygenation (HFNO)

Morbidly obese BMI ≥40 kg/m2 HFNO

EXPERIMENTAL

High-flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: high-flow nasal oxygenation (HFNO)

Interventions

high-flow nasal oxygenation (HFNO) DEVICE

Experimental HFNO: O2 flow 40L/min, FiO2 40%

Morbidly obese BMI ≥40 kg/m2 HFNO; Normal weight 18<BMI<30 kg/m2 HFNO; Obese 30<BMI<40 kg/m2 HFNO

low-flow nasal oxygenation (LFNO) DEVICE

Active comparator (LFNO): O2 flow 5L/min, FiO2 40%

Morbidly obese BMI ≥40 kg/m2 LFNO; Normal weight 18<BMI<30 kg/m2 LFNO; Obese 30<BMI<40 kg/m2 LFNO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal weight (18\<BMI\<30 kg/m2)
• obese patients (30\<BMI\<40 kg/m2)
• morbidly obese patients (BMI≥40 kg/m2)
• intravenous analgo-sedation
• elective colonoscopy
• colorectal tumors.

You may not qualify if:

• emergency colonoscopy
• diseases of peripheral blood vessels
• hematological diseases
• psychiatric diseases
• sideropenic anemia
• patients' refusal
• ongoing chemotherapy or irradiation
• propofol allergies
• fentanyl allergies.

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• General Hospital Dubrovnik: collaborator

Related Publications (14)

• 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.

  PMID: 17579505 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.

  PMID: 24634712 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.

  PMID: 29719796 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.

  PMID: 23740356 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.

  PMID: 24182650 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.

  PMID: 26106206 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.

  PMID: 28089816 BACKGROUND

• Nathanson V. Revising the Declaration of Helsinki. BMJ. 2013 May 8;346:f2837. doi: 10.1136/bmj.f2837. No abstract available.

  PMID: 23657182 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.

  PMID: 20410783 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.

  PMID: 17931878 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.

  PMID: 23845744 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.

  PMID: 27372775 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.

  PMID: 30227319 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.

  PMID: 26545146 BACKGROUND

Related Links

• American Society of Anesthesiologists (ASA). ASA physical status classification system 2014 Oct \[internet\]. Schaumburg, Illinois, USA: ASA;2014.
• Programiz \[internet\].Kupandole, Nepal: Parewa Labs Pvt. Ltd. \[cited 2018 Sept17\]. Flowchart in programming. Available from:

MeSH Terms

Conditions

Respiratory Insufficiency; Obesity; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Central Study Contacts

Anita Vukovic, MD

CONTACT

0989264821; anita_vukovic1@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, specialist of anesthesiology, reanimatology and intensive care

Model Details: 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\<BMI\<30 kg/m2, 30\<BMI\<40 kg/m2 or BMI ≥40 kg/m2. Each group will be divided in control groups of 21 patients who will receive LFNO and intervention groups of 21 patients who will receive HFNO during standardized intravenous analgo-sedation.

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: September 27, 2018
• Study Start: October 30, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2020
• Last Updated: September 27, 2018

Record last verified: 2018-09