- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03492008
Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation
Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation in Anesthetised Intubated Patients: A Prospective Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.
Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.
Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
- aged 20 to 70 years old
- with normal airway (Commack Lehane 1 or 2) and neck movements.
Exclusion Criteria:
- Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional technique
Nasogastric tube
|
Nasogastric tube insertion with patient's head in neutral position
|
|
Eksperimentel: Contralateral cricothyroid pressure
Nasogastric tube
|
Cricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion.
|
|
Eksperimentel: Ipsilateral head turning
Nasogastric tube
|
Patient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall success rate
Tidsramme: At induction of general anesthesia
|
Percentage
|
At induction of general anesthesia
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First attempt success rate
Tidsramme: At induction of general anesthesia
|
Percentage
|
At induction of general anesthesia
|
|
Time taken to successful nasogastric tube placement
Tidsramme: At induction of general anesthesia
|
Procedure start time is defined as the time when the nasogastric tube is inserted through the nostril.
The procedure end time is defined as the time of successful insertion and confirmed NGT placement or the time after two failed attempts.
The outcome is measured in second.
|
At induction of general anesthesia
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sook Hui Chaw, M.Med, University of Malaya
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 201510-1718
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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