Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04135651
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2019-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.\n\nThe interventional process covers opaque clothes.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double blinded clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-10-20', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubation', 'timeFrame': 'During anesthesia induction procedure', 'description': 'The duration from when Pentax pass the tooth to confirm the successful intubation using capnography'}], 'secondaryOutcomes': [{'measure': 'The percentage of glottic opening (POGO) score', 'timeFrame': 'During anesthesia induction procedure', 'description': 'The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%'}, {'measure': 'Cormack-Lehane grade', 'timeFrame': 'During anesthesia induction procedure', 'description': 'The grade of glottic opening by intubation device (1= Full view of glottis, easy; 4=Neither glottis nor epiglottis seen, difficult)'}, {'measure': 'Intubation difficulty scale (IDS)', 'timeFrame': 'During anesthesia induction procedure', 'description': 'The intubation difficulty scale by the sum of seven variables (N1-N7). N1= the number of additional intubation attempts, N2= the number of additional operators, N3= the number of alternative intubation techniques used, N4= the laryngoscopic view, as defined by Cormack and Lehane, N5= the lifting force applied during laryngoscopy, N6= to the necessity to apply external laryngeal pressure to optimize glottic exposure, N7= vocal cord mobility. The IDS score is the sum of N1 through N7. The total IDS score ranges from zero (easy) to infinity (difficult).'}, {'measure': 'Intubation difficulty by NRS score', 'timeFrame': 'During anesthesia induction procedure', 'description': 'Intubation difficulty by NRS score (0=easy, 10=the most difficult)'}, {'measure': 'Success rate in first attempt', 'timeFrame': 'During anesthesia induction procedure', 'description': 'Successful intubation in a first attempt'}, {'measure': 'Hemodynamic changes', 'timeFrame': 'During anesthesia induction procedure', 'description': 'Blood pressure (mmHg) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation'}, {'measure': 'Hemodynamic changes', 'timeFrame': 'During anesthesia induction procedure', 'description': 'Heart rate (bpm) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation'}, {'measure': 'Postoperative complications', 'timeFrame': 'An average of 1 hours after extubation', 'description': 'Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paratracheal pressure', 'Glottic view', 'Cricoid pressure', 'Pentax'], 'conditions': ['Anesthesia', 'Intubation; Difficult or Failed', 'Cricoid Pressure', 'Pulmonary Aspiration During Anesthetic Induction']}, 'descriptionModule': {'briefSummary': 'Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.', 'detailedDescription': 'Primary outcome\n\n\\- Duration of intubation\n\nSecondary outcomes\n\n* POGO (percentage of glottic opening) score before and after application of each intervention\n* Glottic grade by Cormack Lehane\n* The success rate in first attempt\n* Intubation difficulty scale\n* Hemodynamics during intubation\n* Postoperative airway complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are undergoing surgery under general anesthesia\n* American Society of Anesthesiologists Classification 1-2\n\nExclusion Criteria:\n\n* Body mass index \\> 35 kg/m2\n* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)\n* Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),'}, 'identificationModule': {'nctId': 'NCT04135651', 'briefTitle': 'Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Effect of Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope', 'orgStudyIdInfo': {'id': 'MED-INT-19-340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paralaryngeal pressure', 'description': 'During the induction of anesthesia, left paratracheal pressure is applied by 30N force with thumb after confirmation of the location of the esophagus using ultrasound.', 'interventionNames': ['Procedure: Paratracheal pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cricoid pressure', 'description': 'During the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers.', 'interventionNames': ['Procedure: Cricoid pressure']}], 'interventions': [{'name': 'Paratracheal pressure', 'type': 'PROCEDURE', 'description': 'To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.', 'armGroupLabels': ['Paralaryngeal pressure']}, {'name': 'Cricoid pressure', 'type': 'PROCEDURE', 'description': 'To apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.', 'armGroupLabels': ['Cricoid pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}