Nasal Ventilation vs Face Mask

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03853239
Collaborator
(none)
40
1
2
5
8

Study Details

Study Description

Brief Summary

Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults.

Forty patients were randomly assigned (sealed envelope method) to face mask(Group A,n=20)or nasal ventilation(Group B,n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.

Condition or Disease Intervention/Treatment Phase
  • Procedure: face mask ventilation crossover nasal ventilation
  • Procedure: nasal ventilation crossover face mask ventilation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults
Anticipated Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: face mask crossover nasal ventilation

Procedure: face mask ventilation crossover nasal ventilation
Group A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique.

Active Comparator: nasal ventilation crossover face mask

Procedure: nasal ventilation crossover face mask ventilation
Group B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique.

Outcome Measures

Primary Outcome Measures

  1. Difference in expired tidal volume of each technique under pressure-controlled mode [3 breaths of expired tidal volume for each technique]

  2. Difference in air leakage of each technique under volume-controlled mode [3 breaths of air leakage for each technique]

Secondary Outcome Measures

  1. number of participants with Oxygen Saturation- Reading Below 95% [intraoperative duration of each ventilation technique]

  2. peak inspiratory pressure [intraoperative duration of each ventilation technique]

  3. end tidal CO2 partial pressure Reading- Median [intraoperative duration of each ventilation technique]

  4. hemodynamic changes [intraoperative duration of each ventilation technique]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age between 18-55 years old

  • ASA physical status I and II

  • Requiring general anesthesia with nasal intubation

Exclusion Criteria:
  • Respiratory disease,cardiovascular disease, cerebral vascular disease

  • Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring)

  • The need for emergency surgery

  • Contraindications to nasal intubation

  • Pregnancy

  • Gastric-esophageal reflex or a full stomach

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200011

Sponsors and Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yu Sun, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT03853239
Other Study ID Numbers:
  • nasal ventilation vs face mask
First Posted:
Feb 25, 2019
Last Update Posted:
Mar 7, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Sun, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Results

No Results Posted as of Mar 7, 2019