Orogastric Versus Nasogastric Intubation
Condition: Feeding Patterns
Study type: Interventional

Summary: 
      Feeding by tube is commonly used for inpatients and ambulatory patients. For this purpose
      nasogastric (NG) intubation is the traditional approach. The aim of this study was to develop
      the orogastric (OG) intubation with dental fixation and compare OG versus NG intubation in
      healthy volunteers.
    

Detailed description: 
      In this randomized, open label, clinical trial with crossing over design, 13 healthy
      individuals were invited to participate. The study was performed at Hospital São Vicente de
      Paulo between July and December 2017. Those who accepted were studied after signing an
      informed consent form. Sample estimation (software WinPEPI) indicated that 13 participants
      would be enough to show a difference between OGI and NGI of 1 hour in terms of tolerance (SD
      30 min), with alpha 5% and power of 80%. Inclusion criteria were age between 18 and 70 years,
      absence of any acute or chronic disease and intact upper posterior molars or premolars. The
      study was conducted according to rules of the Helsinki declaration and was approved by the
      local Ethical Committee (number 1.942.505).

      The participants were randomly allocated to OG and NG intubations with a 15 days interval.
      Randomization was carried out with computed generated aleatory numbers. A trained dentist
      (RS) performed OG intubation with dental fixation. After explanation about the procedure, the
      patient was placed in Fowler position (45º) and intraoral infiltrative anesthesia was carried
      out with Lidocaine 2% (without vasoconstrictor) at gingival papilla in the
      vestibular-palatine direction. A polyurethane enteral tube (Medicone®, Cachoeirinha - Brazil)
      was inserted through the mouth and passed into de stomach, followed by fixation of the tube
      tip to a superior molar or premolar, in its palatine surface. For dental amarry we used a
      suture wire in stainless steel size 1.0 (Johnson & Johnson - Ethicon, São Paulo, Brazil).

      NG intubation followed the traditional steps described elsewhere and was executed by the
      first author (RS). Briefly, after nostril anesthesia with xylocaine gel, a polyurethane
      enteral tube was inserted through the nose and its tip was positioned in the gastric lumen,
      according to the nose-ear-xiphoid method. The tube was attached to the face using
      antiallergic adhesive tape.

      During both OG and NG intubations the participants were monitored regarding the occurrence of
      nausea, vomit, cyanosis, dyspnea, cough and discomfort. A bottle containing 900 ml of enteral
      diet (1.5kcal/ml, Nutrison Energy - Danone®, São Paulo - Brazil) was provided for each
      participant, with instructions of use. They were explained how to manually remove the tube if
      necessary, and asked to return to the hospital in the following day.

      The main efficacy outcome was tolerance in hours. After intubation patients were asked to
      return in 24 hours for tube removal, but were allowed to withdraw the tube at any time in
      case of substantial discomfort. Secondary outcomes were discomfort, handling, speech,
      mastication, deglutition and esthetic. These efficacy outcomes were assessed using a
      self-reporting questionnaire in which participants were asked to reply after tube removal.
      Each outcome was rated by means of a 10-item Likert scale (0 = best / 10 = worst). Safety
      outcomes were registered either by the researcher during the intubation procedure (placement
      and removal) or by the participants replying an open question: "please describe any complaint
      related with the intubation".
    

Intervention name(s): Orogastric intubation; Nasogastric intubation
Intervention type(s): Device; Device
Intervention description(s): Patient was placed in Fowler position (45º) and intraoral infiltrative anesthesia was carried out with Lidocaine 2% (without vasoconstrictor) at gingival papilla in the vestibular-palatine direction. A polyurethane enteral tube (Medicone®, Cachoeirinha - Brazil) was inserted through the mouth and passed into de stomach, followed by fixation of the tube tip to a superior molar or premolar, in its palatine surface. For dental amarry it waas used a suture wire in stainless steel size 1.0; After nostril anesthesia with xylocaine gel, a polyurethane enteral tube was inserted through the nose and its tip was positioned in the gastric lumen, according to the nose-ear-xiphoid method. The tube was attached to the face using antiallergic adhesive tape.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cross-over randomized trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasogastric intubation; Orogastric intubation; Feeding tubes