The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients

NCT03687385 | Unknown

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

Brief Summary

Analgo-sedation is standard procedure in anesthesiology practice and is often given for colonoscopy in the setting of daily hospital. Ideally, patients should be sedated with preserved spontaneous breathing and adequate blood O2 saturation. To maintain adequate oxygenation, low-flow O2 (2-6 L/min) is usually delivered through standard nasal catheter which can provide inspired fraction (FiO2) of 40% (low-flow nasal oxygenation - LFNO). Coldness and dryness of LFNO applied may be uncomfortable to patient. Standardly applied intravenous anesthetics can lead to transient ceasing of breathing and O2 desaturation despite LFNO. Respiratory instability can also potentiate circulatory instability - undesirable changes in heart rate (HR) and blood pressure (BP). Unlike LFNO, high-flow heated and humidified nasal oxygenation (HFNO) is characterized by the oxygen-air mixture flow of 20 to 70 L/min up to 100% FiO2. Warm and humidified O2, delivered via soft, specially designed nasal cannula, is pleasant to patient. HFNO develops continuous positive pressure of 3 to 7 cmH2O in upper airway which enables noninvasive support to patient's spontaneous breathing thus prolonging time of adequate O2 saturation. Aim of this study is to compare effect of HFNO and LFNO on oxygenation maintenance before, during and after standardized procedure of intravenous analgo-sedation in normal weight patients of ASA risk I, II and III. Investigators hypothesize that application of HFNO compared to LFNO, in patients with preserved spontaneous breathing during procedural analgo-sedation, will contribute to maintaining of adequate oxygenation, consequentially adding to greater circulatory and respiratory patients' stability. Investigators expect that patients who receive HFNO will better maintain adequate oxygenation regarding improved spontaneous breathing. Also patients will have shorter intervals of blood oxygen desaturation, less pronounced rise in blood CO2 level and lesser fall of blood O2 level, less change in HR and BP. Investigators will have to exactly estimate partial and global respiratory insufficiency (blood CO2 and O2 levels) associated with LFNO and HFNO, which will be done by blood-gas analysis of 3 arterial blood samples collected before, during and after analgo - sedation via previously, in local anesthesia, placed arterial cannula. Possible complications will be explained in written uniformed consent and by anesthesiologist.

Conditions

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

Keywords

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

ASA I / LFNO

ACTIVE COMPARATOR

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

Device: low-flow nasal oxygenation (LFNO)

ASA II / LFNO

ACTIVE COMPARATOR

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

Device: low-flow nasal oxygenation (LFNO)

ASA III / LFNO

ACTIVE COMPARATOR

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

Device: low-flow nasal oxygenation (LFNO)

ASA I / HFNO

EXPERIMENTAL

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

Device: high-flow nasal oxygenation (HFNO)

ASA II/ HFNO

EXPERIMENTAL

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

Device: high-flow nasal oxygenation (HFNO)

ASA III/ 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%

ASA I / HFNO; ASA II/ HFNO; ASA III/ HFNO

low-flow nasal oxygenation (LFNO) DEVICE

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

ASA I / LFNO; ASA II / LFNO; ASA III / 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 ASA I patient
• normal weight ASA II patient
• normal weight ASA III patient
• intravenous analgo-sedation
• elective colonoscopy
• colorectal tumors.

You may not qualify if:

• obese patients
• 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

• Anita Vukovic: lead
• General Hospital Dubrovnik: collaborator
• Clinical Hospital Centre Zagreb: collaborator

Related Publications (10)

• Behrens A, Ell C; Studiengruppe ALGK-ProSed. [Safety of sedation during gastroscopy and colonoscopy in low-risk patients - results of a retrospective subgroup analysis of a registry study including over 170 000 endoscopies]. Z Gastroenterol. 2016 Aug;54(8):733-9. doi: 10.1055/s-0042-108655. Epub 2016 Aug 16. German.

  PMID: 27529524 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

• 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

• 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

• Booth AWG, Vidhani K, Lee PK, Thomsett CM. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth. 2017 Mar 1;118(3):444-451. doi: 10.1093/bja/aew468.

  PMID: 28203745 BACKGROUND

• Schumann R, Natov NS, Rocuts-Martinez KA, Finkelman MD, Phan TV, Hegde SR, Knapp RM. High-flow nasal oxygen availability for sedation decreases the use of general anesthesia during endoscopic retrograde cholangiopancreatography and endoscopic ultrasound. World J Gastroenterol. 2016 Dec 21;22(47):10398-10405. doi: 10.3748/wjg.v22.i47.10398.

  PMID: 28058020 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

• Morris K. Revising the Declaration of Helsinki. Lancet. 2013 Jun 1;381(9881):1889-90. doi: 10.1016/s0140-6736(13)60951-4. No abstract available.

  PMID: 23734387 BACKGROUND

• Moher D, Schulz KF, Altman DG; CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Investig. 2003 Mar;7(1):2-7. doi: 10.1007/s00784-002-0188-x. Epub 2003 Jan 31.

  PMID: 12673431 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; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anita Vukovic, MD

CONTACT

0989264821; anita_vukovic1@yahoo.com

Dubravka Bartolek Hamp, Assist Prof

CONTACT

0911963033; dbartolekh@gmail.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: SPONSOR 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 normal weight patients of anesthesia risk ASA class I, II or III divided in three groups of 42. Each group will be divided in control subgroups of 21 patients who will receive low-flow nasal oxygenation (LFNO) and intervention subgroups of 21 patients who will receive high-flow nasal oxygenation (HFNO) during standardized intravenous analgo-sedation.

Study Record Dates

• First Submitted: September 21, 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