Trial Outcomes & Findings for Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency (NCT NCT02780765)

Last Updated: 2018-09-20

Results Overview

The bevel end \& Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured \& noted

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

At baseline just before intubation and 24 hours from time of ICU admission

Results posted on

2018-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Heated Humidifier Group 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)	Mist Humidifier Group 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heated Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)	Mist Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=30 Participants	20 Participants n=30 Participants	42 Participants n=60 Participants
Age, Categorical >=65 years	8 Participants n=30 Participants	10 Participants n=30 Participants	18 Participants n=60 Participants
Age, Continuous	48.57 years STANDARD_DEVIATION 10.34 • n=30 Participants	50.60 years STANDARD_DEVIATION 11.60 • n=30 Participants	49.58 years STANDARD_DEVIATION 10.82 • n=60 Participants
Sex: Female, Male Female	8 Participants n=30 Participants	9 Participants n=30 Participants	17 Participants n=60 Participants
Sex: Female, Male Male	22 Participants n=30 Participants	21 Participants n=30 Participants	43 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: At baseline just before intubation and 24 hours from time of ICU admission

Outcome measures

Outcome measures
Measure	Heated Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)	Mist Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume	8.81 percentage change of ET tube volume Standard Deviation 6.35	14.08 percentage change of ET tube volume Standard Deviation 6.66

PRIMARY outcome

Timeframe: At baseline just before intubation and 24 hours from time of ICU admission

Population: The bevel end \& Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured \& noted

Investigators will assess nursing workload by frequency of filling of humidifier chamber.

Outcome measures

Outcome measures
Measure	Heated Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)	Mist Humidifier Group n=30 Participants 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
Assess the Increase in Nurses Work Load	0.0 time of refilling of nebuliser chamber Standard Deviation 0.0	3.5 time of refilling of nebuliser chamber Standard Deviation 0.99

Adverse Events

Heated Humidifier Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mist Humidifier Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Vijaya Patil

Tata Memorial Hospital, Mumbai

Phone: +91-2224177000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place