Hypoxia Clinical Trial
Official title:
The Comparison of Low- and High-flow Nasal Oxygenation to the Blood Oxygen Saturation During Analgo-sedation in ASA Risk Class I, II and III Normal Weight Patients: Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 126 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - normal weight ASA I patient - normal weight ASA II patient - normal weight ASA III patient - intravenous analgo-sedation - elective colonoscopy - colorectal tumors. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Anita Vukovic | Clinical Hospital Centre Zagreb, General Hospital Dubrovnik |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. French. — View Citation
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. Epub 2003 Jan 31. — View Citation
Morris K. Revising the Declaration of Helsinki. Lancet. 2013 Jun 1;381(9881):1889-90. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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