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Clinical Trials/CTRI/2020/03/023855
CTRI/2020/03/023855Not yet recruitingNot Applicable

Comparison of oxygen delivery methods for patient undergoing monitored anesthesia care in endoscopic procedures.

Pramukhswami medical college1 site in 1 country66 target enrollmentStarted: October 3, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
66
Locations
1
Primary Endpoint
Hypoxia

Study Overview

Brief Summary

Patient will undergo pre-anesthesia workup ,written and informed consent will be taken. All patient will be kept nil by mouth 8 hrs for solid 2 hrs for clear liquid, patient with concurrent illness take medication.Preprocedural preaparation by lidocaine oral topical solution, topical pharyngeal spray with 10% lidocaine spray for upper endoscopy. Patient randomly allocated into two group using winpipe software a) nasal prongs b) t piece via nasopharyngeal airway with FiO2 between 40-60%. Patients vitals(Spo2, heart rate,respiratory rate,blood pressure) are monitored on table, every 5 mins till the end of procedure. Adverse events and correction done such as hypoxia- head tilt, chin lift,securing airway by nasopharyngeal airway, increase flow of O2 or intermittent O2 flush, bag and mask ventilation, bradycardia- fluid and vasopressor, body movement - additional dose of anesthetic drug, bleeding from nose - local pressure application, Aspiration- oral nasal suctioning interruption of procedure and securing definite airway , Ramsay sedation score will be maintained >4 during endoscopy. We focus on comparing two different methods of oxygen delivery in flexible endoscopic procedure and thereby finding out the best method of oxygen delivery for safe and efficient monitored anesthesia care for patients undergoing flexible endoscopic procedure.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •All patients ASA I,II,III, IV undergoing flexible endoscopy under monitored anesthesia care.

Exclusion Criteria

  • •Patient requiring endotracheal intubation 2) Patient who have endotracheal tube insitu 3) Inadequate NBM 4) Tracheostomised patient 5) Allergy to topical anesthetics 6) Nasal deformities(deformation of nasal septum, visible distorsion or deviation from midline of nasal septum) 7) Patient on anticoagulants and with deranged coagulation profile 8)Lack of informed consent.

Outcomes

Primary Outcomes

Hypoxia

Time Frame: SPO2 less than 90 percentage for at least 15 secconds

Secondary Outcomes

  • 1) Vitals and sedation level(2) Adverse events)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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